Spiriva

(Tiotropium)

ApprovedSmall molecule

Tiotropium is used to treat chronic obstructive pulmonary disease (COPD) and asthma by helping to open airways and make breathing easier. It is a long-acting maintenance medication that people inhale once daily to prevent symptoms.[2] Spiriva is currently approved and in use across 8 indications[4].[1]

Spiriva is one of 199 small molecule programs targeting Bronchial Obstruction. It is currently in Approved.

Indications

162

Total Trials

Active Trials

198

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bronchial ObstructionNot yet recruiting

Renal InsufficiencyApproved

Spinal Cord InjuryApproved

Cystic FibrosisApproved

EmphysemaActive, not recruiting

COPDCompleted

Chronic Obstructive Pulmonary DiseaseCompleted

AsthmaNot yet recruiting

Bronchial ObstructionApproved

Not yet recruiting

Renal InsufficiencyApproved

Approved

Spinal Cord InjuryApproved

Approved

Cystic FibrosisApproved

Approved

EmphysemaPreclinical

Active, not recruiting

COPDApproved

Completed

Chronic Obstructive Pulmonary DiseaseApproved

Completed

AsthmaApproved

Not yet recruiting

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Spiriva

Boehringer Ingelheim

Approved

8 2

Celexa

AbbVie

Preclinical

1 3

Arcoxia

Novartis

Preclinical

—4

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 5

DUPIXENT

Regeneron

Preclinical

1 6

Paracetamol

GSK

Preclinical

1 7

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 8

Aclidinium Bromide

AstraZeneca

Preclinical

—9

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 10

Lexapro

SShirley Ryan AbilityLab

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalNot yet recruiting

Asthma

NCT06679465

Q3 2029

ApprovedNot yet recruiting

Bronchial Obstruction

NCT07827859

Clinical

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease70 trials

Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China

Completed·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 4·NCT01455129·841 enrolled

Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01431287·2,539 enrolled

Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01285492·160 enrolled

Show 67 more trials

A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)

Completed·MMylan Inc.·Phase 3·NCT02518139·1,060 enrolled

Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT01072396·126 enrolled

Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01431274·2,624 enrolled

Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00281567·76 enrolled

Efficacy, Safety, and Tolerability of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01613326·657 enrolled

Pilot Study Comparing Tiotropium (Spiriva) to Salmeterol (Serevent) Plus Fluticasone (Flixotide) in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00239499·107 enrolled

A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT01708057·3 enrolled

Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00435760·115 enrolled

The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01574651·934 enrolled

The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT03240575·302 enrolled

Cardiac Limitations in Chronic Obstructive Pulmonary Disease: Benefits of Bronchodilation

Completed·MMayo Clinic·Phase 4·NCT00578968·36 enrolled

1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT00929110·1,066 enrolled

A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 2·NCT01372410·163 enrolled

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 4·NCT03478696·732 enrolled

Tiotropium (18mcg) in Chronic Obstructive Pulmonary Disease (COPD) Patients With a Respiratory Infection

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT01483625·140 enrolled

Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease

Completed· GSK logo

GSK·Phase 1·NCT00279019·31 enrolled

Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00523991·457 enrolled

Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02006732·809 enrolled

The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01490125·247 enrolled

Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

Completed·TThe Korean Academy of Tuberculosis and Respiratory Diseases·Phase 4·NCT00864812·509 enrolled

Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01964352·813 enrolled

A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 4·NCT03474081·800 enrolled

Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

Completed· Novartis logo

Novartis·Phase 1·NCT00532350·22 enrolled

A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 4·NCT03478683·729 enrolled

Comparison of Long-term Safety of the Combination Product QVA149A Against Placebo and Standard of Care Treatment in Chronic Obstructive Pulmonary Disease Patients With Moderate to Severe Airflow Limitation

Completed· Novartis logo

Novartis·Phase 3·NCT01610037·1,215 enrolled

A Study of Arformoterol Tartrate Inhalation Solution and Tiotropium Bromide on Re-hospitalization in Chronic Obstructive Pulmonary Disease (COPD) Subjects

Terminated· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 4·NCT02275481·66 enrolled

Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02296138·7,903 enrolled

Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01462929·414 enrolled

The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00939211·25 enrolled

Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol on Muscular Efficiency and Resting Energy Expenditure (REE) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02172794·48 enrolled

Free Combinations of Tiotropium Inhalation Powder Capsule + Salmeterol Metered Dose Inhaler, Tiotropium Inhalation Powder Capsule and Salmeterol Metered Dose Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02242253·97 enrolled

Tiotropium (18 Mcg) Once Daily Via the HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274547·1,829 enrolled

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT01397890·793 enrolled

Effect of Tiotropium on Eye Findings in the Treatment of Chronic Obstructive Pulmonary Disease

Completed·GGiresun University··NCT06525051·108 enrolled

Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK·Phase 2·NCT00422604·60 enrolled

Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01294787·85 enrolled

Efficacy and Safety of Free Combination of Tiotropium + Formoterol Compared to Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02238119·74 enrolled

Outcomes and Costs Associated With Initiating Maintenance Treatment With Fluticasone Propionate 250mcg/Salmeterol Xinafoate 50mcg Combination (FSC) Versus Anticholinergics Including Tiotropium (TIO) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· GSK logo

GSK··NCT01331694·76,130 enrolled

Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 4·NCT00424528·235 enrolled

Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 4·NCT01922271·152 enrolled

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease

Completed· GSK logo

GSK·Phase 3·NCT02207829·1,017 enrolled

Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT00624377·2,031 enrolled

Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01068613·62 enrolled

GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

Completed· GSK logo

GSK·Phase 2·NCT00950807·176 enrolled

Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01559116·219 enrolled

Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium

Completed· Novartis logo

Novartis·Phase 2·NCT00501852·83 enrolled

A Collection of Vital Status and Pulmonary Medication Usage Data for Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Withdrew Prematurely From Tiotropium Inhalation Solution Delivered by the Respimat Inhaler

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02172560·441 enrolled

Effects of Long Acting Bronchodilators on CARDiac Autonomic Control in Chronic Obstructive Pulmonary Disease (COPD)

Completed·—·Phase 4·NCT02872090·42 enrolled

A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT01202188·2,144 enrolled

Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00662740·220 enrolled

Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02172287·623 enrolled

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 2/3·NCT00463567·2,059 enrolled

Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00868231·30 enrolled

A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Novartis logo

Novartis·Phase 3·NCT00900731·1,598 enrolled

Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01040689·108 enrolled

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00877383·1,142 enrolled

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

Completed· Novartis logo

Novartis·Phase 3·NCT00846586·1,134 enrolled

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01126437·17,183 enrolled

A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease

Withdrawn· Teva logo

Teva·Phase 2·NCT02203474

Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Completed· Novartis logo

Novartis·Phase 3·NCT01513460·773 enrolled

Lung Function Changes Following the Addition of Formoterol to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02242240·95 enrolled

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01040728·122 enrolled

The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed·TThomasTruncale·Phase 1·NCT00870896·5 enrolled

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Completed· Novartis logo

Novartis·Phase 3·NCT00615459·169 enrolled

Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease

Completed· GSK logo

GSK·Phase 2·NCT00515502·24 enrolled

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT01911364·3,686 enrolled

Pharmacokinetics and Safety of BI 1744 CL Plus Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02231177·47 enrolled

COPD13 trials

Comparison of Indacaterol With That of Placebo in 'Maintenance naïve' Patients With COPD Using Blinded Tiotropium as Active Control

Withdrawn· Novartis logo

Novartis·Phase 4·NCT01715311

Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT00615992·754 enrolled

Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02969317·12 enrolled

Show 10 more trials

Efficiency of Twice Daily Formoterol Versus Once Daily Tiotropium in Patients With GOLD A/B COPD

Unknown status·HHuashan Hospital·N/A·NCT03258749·120 enrolled

Tiotropium / Respimat One Year Study in COPD.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00387088·3,991 enrolled

Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Terminated· Otsuka logo

Otsuka·Phase 4·NCT00394485·50 enrolled

Effects of Tiotropium on Walking Capacity in Patients With COPD

Completed·LLaval University·Phase 4·NCT01307189·33 enrolled

Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02853123·106 enrolled

Dose Finding Study in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00122434·389 enrolled

Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02683109·221 enrolled

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

Completed·TTheravance Biopharma·Phase 4·NCT05165485·404 enrolled

Tiotropium Respimat Pharmacokinetic Study in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01222533·154 enrolled

Indacaterol Versus Tiotropium on Dynamic Hyperinflation in COPD

Completed·IIrmandade Santa Casa de Misericórdia de Porto Alegre·Phase 4·NCT01693003·20 enrolled

Efficacy and Safety8 trials

Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00662792·147 enrolled

Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02242279·37 enrolled

Efficacy and Safety (Including 24-hour Holter Monitoring) of Tiotropium Inhalation Capsules in Patients With COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00239460·196 enrolled

Show 5 more trials

Comparison of Tiotropium and Ipratropium in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274040·141 enrolled

Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00535366·103 enrolled

Efficacy and Safety of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass Exposure

Completed·NNational Institute of Respiratory Diseases, Mexico·Phase 4·NCT05506865·73 enrolled

A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

Completed· Novartis logo

Novartis·Phase 4·NCT02566031·379 enrolled

Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00239447·131 enrolled

Asthma8 trials

An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00365560·115 enrolled

Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma

Withdrawn· GSK logo

GSK·Phase 3·NCT03376932

Exacerbation Risk in Asthma

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05501639·1,899 enrolled

Show 5 more trials

Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics

Completed·TTheron Pharmaceuticals, Inc.·Phase 2·NCT02382510·59 enrolled

Two-part Pharmacokinetic and Pharmacodynamic Study of LAS190792 in Patients With Asthma and COPD

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02059434·55 enrolled

Efficacy and Safety of 2 Doses of Tiotropium Via Respimat in Adult Patients With Mild Persistent Asthma

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01316380·465 enrolled

Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Not yet recruiting·UUniversity of Saskatchewan·Phase 4·NCT06679465·10 enrolled

Tiotropium for Smoking Asthmatics Study

Withdrawn·UUniversity of Alberta·Phase 4·NCT00546234

Salmeterol4 trials

A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274560·653 enrolled

Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01969721·229 enrolled

Tiotropium and Salmeterol PK Study in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00673478·50 enrolled

Show 1 more trial

A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274534·36 enrolled

37 more indications

Moderate to Severe COPD4 trials

Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

Completed· Novartis logo

Novartis·Phase 4·NCT02603393·1,053 enrolled

Effect of Glycopyrronium on Morning Symptoms and Pulmonary Function in Patients With Moderate to Severe COPD

Completed· Novartis logo

Novartis·Phase 4·NCT01959516·124 enrolled

Beta Blocker Therapy in Moderate to Severe COPD

Completed·UUniversity of Dundee·Phase 4·NCT01656005·18 enrolled

Show 1 more trial

Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD

Completed·NNeutec Ar-Ge San ve Tic A.Ş·Phase 4·NCT02541006·58 enrolled

Treatment4 trials

Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00388882·327 enrolled

A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00359788·349 enrolled

The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD

Completed· GSK logo

GSK·Phase 3·NCT01777334·905 enrolled

Show 1 more trial

The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium

Completed· GSK logo

GSK·Phase 3·NCT01899742·497 enrolled

Exercise3 trials

Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01533922·295 enrolled

Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01533935·291 enrolled

Tiotropium In Exercise

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00525512·519 enrolled

Trial3 trials

High Dose Trial in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00128440·78 enrolled

Replication of the INSPIRE Trial in Healthcare Claims Data

Completed·—··NCT05179512·98,278 enrolled

Replication of the POET-COPD Trial in Healthcare Claims Data

Completed·—··NCT05083429·8,716 enrolled

Liver3 trials

Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products

Completed·SSolventum US LLC·Phase 1·NCT02627625·31 enrolled

Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products

Completed·SSolventum US LLC·Phase 1·NCT02676297·26 enrolled

Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference

Completed·SSolventum US LLC·Phase 1·NCT03302065·38 enrolled

Efficacy3 trials

Early Intervention Efficacy in COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04249310·6,788 enrolled

Efficacy in Walked Distance of Indacaterol vs Tiotropium in Women With COPD Secondary to Biomass (EMERALD)

Completed·NNational Institute of Respiratory Diseases, Mexico·Phase 4·NCT02473237·40 enrolled

12 Week Efficacy of Tiotropium Versus Placebo in Patients With Mild COPD According to Swedish Guidelines (SPIRIMILD)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00144196·224 enrolled

Tics2 trials

Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers

Completed·KKindeva Drug Delivery·Phase 1·NCT03246581·40 enrolled

Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01309139·36 enrolled

MPA2 trials

Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium

Completed· GSK logo

GSK·Phase 3·NCT02257385·967 enrolled

Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Completed· Novartis logo

Novartis·Phase 3·NCT00999908·54 enrolled

Function2 trials

Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT02030535·53 enrolled

Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00144339·5,993 enrolled

Quality of Life1 trial

Effects of a 9-months Treatment of SPIRIVA on Health Related Quality of Life in Patients With COPD

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274053·555 enrolled

Scar1 trial

Evaluation of Long-Acting Muscarinic Antagonists in COPD

Completed·UUniversity of Dundee·Phase 4·NCT02039050·15 enrolled

Monotherapy1 trial

Tiotropium/Formoterol Via Discair® vs Tiotropium Monotherapy or Tiotropium + Formoterol Free Combination Treatment

Completed·NNeutec Ar-Ge San ve Tic A.Ş·Phase 4·NCT02988869·84 enrolled

Gastrointestinal1 trial

Effect of Charcoal on Gastrointestinal Absorption of Tiotropium

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT03945344·20 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study of Glyco pMDI After Single and Repeated Administration

Completed· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 1/2·NCT01176903·65 enrolled

CHOP1 trial

Duration of Long Acting Muscarinic Antagonist (LAMA) Bronchoprotection Against Methacholine Challenge

Completed·UUniversity of Saskatchewan·Phase 4·NCT02622243·13 enrolled

Non-Small Cell Lung Cancer1 trial

Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer

Unknown status·HHamilton Health Sciences Corporation·Phase 2·NCT01172925·34 enrolled

Respiratory Disorders1 trial

Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274014·1,000 enrolled

Female1 trial

Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02172417·18 enrolled

Pulmonary Function1 trial

Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI

Unknown status·JJames J. Peters Veterans Affairs Medical Center·Phase 1·NCT01355991·40 enrolled

Physical Activity1 trial

Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02629965·184 enrolled

Sts1 trial

Blacks and Exacerbations on Long Acting Beta Agonists (LABA) vs. Tiotropium (BELT)

Completed·—·Phase 3·NCT01290874·1,070 enrolled

Emphysema1 trial

Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

Completed·GGelb, Arthur F., M.D.··NCT00570544·29 enrolled

Patient Preference1 trial

Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

Completed· Novartis logo

Novartis·Phase 4·NCT02125734·88 enrolled

Chronic Lung Disease1 trial

To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02085161·304 enrolled

Sleep1 trial

Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients

Completed·UUniversity of Crete·N/A·NCT02331940·200 enrolled

Satisfaction1 trial

Study Evaluating Preference, Satisfaction And Correct Use Of Inhalers In COPD Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01727024·140 enrolled

Cardiovascular Function1 trial

Cardiovascular Function in COPD Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT03055988·76 enrolled

Chronic1 trial

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations

Completed· Novartis logo

Novartis·Phase 3·NCT01120691·2,224 enrolled

ESS1 trial

Spiriva® Assessment of FEV1 (SAFE)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00277264·914 enrolled

Corticosteroids1 trial

Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT05402020·17,018 enrolled

Phase II1 trial

AMPLIFY - D6571C00001 Duaklir USA Phase III Study

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02796677·1,595 enrolled

Rehabilitation1 trial

Tiotropium (Spiriva) Rehabilitation Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00274521·108 enrolled

Inflammation1 trial

Effect of Tiotropium on Inflammation and Exacerbations in COPD

Completed·—·Phase 4·NCT00405236·220 enrolled

Arterial Stiffness1 trial

A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD

Completed· GSK logo

GSK·Phase 3·NCT01395888·260 enrolled

Bronchial Obstruction1 trial

A Prospective, Randomized, Controlled, Crossover Phase IV Study to Evaluate the Efficacy and Safety of Inhaled Tiotropium in Preterm Infants With Bronchial Obstruction Compared to Standard Treatment

Not yet recruiting·GGeneral University Hospital, Prague·Approved·NCT07827859·50 enrolled

Pulmonary Disease, Chronic Obstructive1 trial

A 24-week (+ 24 Week Extension) Placebo-controlled (Only 1st 12-week Period), Double-Blind, Parallel-group, Efficacy and Safety Comparison of Fixed-dose Combination (FDC) Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol Plus Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) Patients

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00668772·207 enrolled

Unspecified6 trials

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01694771·1,134 enrolled

Exacerbation Study

Completed· Novartis logo

Novartis·Phase 3·NCT00845728·3,439 enrolled

Co-administration of Olodaterol Respimat® and Tiotropium Handihaler®

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01696058·1,137 enrolled

Show 3 more trials

Effect of Indacaterol on Inspiratory Capacity (IC)

Completed· Novartis logo

Novartis·Phase 3·NCT01012765·173 enrolled

A Prescription-Event Monitoring (PEM) Study of Tiotropium

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02196194·13,891 enrolled

Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01119937·211 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 30, 2004

SPIRIVA

NDA NDA021395

Aug 23, 2004

SPIRIVA

NDA NDA021395

Sep 20, 2006

SPIRIVA

NDA NDA021395

Dec 8, 2006

SPIRIVA

NDA NDA021395

Dec 8, 2006

SPIRIVA

NDA NDA021395

Jun 20, 2008

SPIRIVA

NDA NDA021395

Nov 13, 2008

SPIRIVA

NDA NDA021395

Mar 3, 2009

SPIRIVA

NDA NDA021395

Dec 17, 2009

SPIRIVA

NDA NDA021395

Jul 28, 2011

SPIRIVA

NDA NDA021395

Nov 4, 2011

SPIRIVA

NDA NDA021395

Sep 24, 2014

SPIRIVA RESPIMAT

NDA NDA021936

Apr 22, 2015

SPIRIVA

NDA NDA021395

Apr 23, 2015

SPIRIVA

NDA NDA021395

Sep 15, 2015

SPIRIVA RESPIMAT

NDA NDA207070

Sep 15, 2015

SPIRIVA RESPIMAT

NDA NDA021936

Oct 26, 2015

SPIRIVA

NDA NDA021395

Dec 10, 2015

SPIRIVA

NDA NDA021395

Jan 15, 2016

SPIRIVA RESPIMAT

NDA NDA021936

Mar 24, 2016

SPIRIVA

NDA NDA021395

Apr 29, 2016

SPIRIVA

NDA NDA021395

Jun 9, 2016

SPIRIVA RESPIMAT

NDA NDA021936

Jun 23, 2016

SPIRIVA

NDA NDA021395

Feb 15, 2017

SPIRIVA RESPIMAT

NDA NDA021936

Feb 1, 2018

SPIRIVA

NDA NDA021395

Feb 14, 2019

SPIRIVA RESPIMAT

NDA NDA021936

Dec 27, 2024

SPIRIVA RESPIMAT

NDA NDA021936

Dec 30, 2024

SPIRIVA

NDA NDA021395

Sources

References

[1]
ClinicalTrials.gov — 162 trial records for Tiotropium. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Spiriva drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tiotropium compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tiotropium. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021395). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Spiriva. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Boehringer Ingelheim company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M3 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Boehringer Ingelheim

Patent Landscape[6]

Patent Cliff

Mar 31, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8022082Jan 19, 2026

8022082*PEDJul 19, 2026

9027967Mar 31, 2027

7396341*PEDApr 10, 2027

9027967*PEDSep 30, 2027

2 more patents

7837235*PEDSep 13, 2028

8733341*PEDApr 16, 2031

Spiriva

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2029

Trials by Indication[1]

Chronic Obstructive Pulmonary Disease70 trials

COPD13 trials

Efficacy and Safety8 trials

Asthma8 trials

Salmeterol4 trials

Moderate to Severe COPD4 trials

Treatment4 trials

Exercise3 trials

Trial3 trials

Liver3 trials

Efficacy3 trials

Tics2 trials

MPA2 trials

Function2 trials

Quality of Life1 trial

Scar1 trial

Monotherapy1 trial

Gastrointestinal1 trial

Safety and Efficacy1 trial

CHOP1 trial

Non-Small Cell Lung Cancer1 trial

Respiratory Disorders1 trial

Female1 trial

Pulmonary Function1 trial

Physical Activity1 trial

Sts1 trial

Emphysema1 trial

Patient Preference1 trial

Chronic Lung Disease1 trial

Sleep1 trial

Satisfaction1 trial

Cardiovascular Function1 trial

Chronic1 trial

ESS1 trial

Corticosteroids1 trial

Phase II1 trial

Rehabilitation1 trial

Inflammation1 trial

Arterial Stiffness1 trial

Bronchial Obstruction1 trial

Pulmonary Disease, Chronic Obstructive1 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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