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Proair HFA

(Albuterol)

ApprovedSmall molecule

GGlaxo Dba Glaxosmithkline

Albuterol is a medication that opens up the airways in your lungs to make breathing easier. It's used to relieve and prevent breathing problems like wheezing, shortness of breath, and chest tightness caused by conditions like asthma and COPD, and can also be used before exercise to prevent breathing difficulties.[2] Proair HFA is currently approved and in use across 34 indications[4].[1]

Proair HFA is one of 640 small molecule programs targeting Bronchiolitis. It is currently in Approved.

34

Indications

57

Total Trials

1

Active Trials

639

Competitors

17

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

BronchiolitisActive, not recruiting

Idiopathic Pulmonary Arterial HypertensionActive, not recruiting

Facioscapulohumeral DystrophyActive, not recruiting

Respiratory FailureApproved

Status AsthmaticusCompleted

Familial DysautonomiaApproved

Airway ObstructionActive, not recruiting

Organophosphate PoisoningApproved

Lung DiseaseApproved

Glycogen Storage Disease Due to Acid Maltase DeficiencyApproved

BronchiolitisPreclinical

Active, not recruiting

Idiopathic Pulmonary Arterial HypertensionPhase 2

Active, not recruiting

Facioscapulohumeral DystrophyPreclinical

Active, not recruiting

Respiratory FailureApproved

Approved

Status AsthmaticusPhase 2

Completed

Familial DysautonomiaApproved

Approved

Airway ObstructionApproved

Active, not recruiting

Organophosphate PoisoningApproved

Approved

Lung DiseaseApproved

Approved

Glycogen Storage Disease Due to Acid Maltase DeficiencyApproved

Approved

Showing 10 of 33 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Proair HFA

GGlaxo Dba Glaxosmithkline

Asmanex

Atrovent

Boehringer Ingelheim

Paracetamol

Blood Withdrawn

Emergent BioSolutions

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Lexapro

SShirley Ryan AbilityLab

Ozone

TTanta University

Spiriva

Boehringer Ingelheim

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

Clinical

Trials by Indication[1]

Asthma19 trials

Genetic Determinants of the Response to Salbutamol Among Asthma Patients

Unknown status·HHadassah Medical Organization·N/A·NCT00162396·150 enrolled

Lung Function of Asthmatic Children by Nebulized MgSO4

Completed·—·N/A·NCT01799109·90 enrolled

Characterization of Placebo Responses in Stable Asthma

Completed·—·N/A·NCT01143688·39 enrolled

Show 16 more trials

Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics

Completed· Teva logo

Teva·Phase 3·NCT00308685·95 enrolled

Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects

Completed· Teva logo

Teva·Phase 2·NCT01772368·72 enrolled

Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4

Completed·—·N/A·NCT01856959·330 enrolled

Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)

Completed·UUniversity of Illinois at Chicago·Phase 3·NCT03137303·402 enrolled

Dose-response of Albuterol in Asthmatics

Completed·NNemours Children's Clinic·Phase 4·NCT00940927·81 enrolled

Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study

Completed·VVanderbilt University Medical Center·N/A·NCT01196377·16 enrolled

Dose Finding Study of Albuterol Sulfate in Patients With Intermittent or Persistent Mild Asthma

Withdrawn·AAcerus Pharmaceuticals Corporation·Phase 2·NCT01252758

Comparison of Breath-Enhanced and T-Piece Nebulizers in Children With Acute Asthma

Completed·SSeton Healthcare Family·N/A·NCT02566902·118 enrolled

Comparison of Nebulizers in ED in Pediatric Asthma Patients

Terminated·SSeton Healthcare Family·Phase 4·NCT01951378·40 enrolled

Asthma Clinical Research Network (ACRN)

Withdrawn·MMilton S. Hershey Medical Center·Phase 3·NCT00000577

Repeat Emergency Department Visits Among Patients With Asthma and COPD

Terminated·SState University of New York at Buffalo·N/A·NCT02499887·6 enrolled

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT01312961·104 enrolled

Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

Completed·NNorthwell Health·Phase 3·NCT00588406·95 enrolled

A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma

Completed· Teva logo

Teva·Phase 4·NCT03890666·333 enrolled

Albuterol HFA MDI in Pediatric Participants With Asthma

Completed· Teva logo

Teva·Phase 3·NCT00577655·103 enrolled

A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

Completed· Teva logo

Teva·Phase 4·NCT04677959·427 enrolled

Status Asthmaticus2 trials

Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus

Completed·UUniversity Hospitals Cleveland Medical Center·Phase 1·NCT02872597·30 enrolled

Dose Escalation Clinical Trial of High-dose Oral Montelukast to Inform Future RCT in Children With Acute Asthma Exacerbations

Completed·VVanderbilt University Medical Center·Phase 2·NCT05819541·90 enrolled

Chronic Obstructive Pulmonary Disease2 trials

Batefenterol/Fluticasone Furoate in Treatment of Chronic Obstructive Pulmonary Disease

Completed· GSK logo

GSK·Phase 2·NCT02573870·63 enrolled

Bronchodilator Test in Mechanical Ventilated Chronic Obstructive Pulmonary Disease Patients

Unknown status·—·N/A·NCT02218398·120 enrolled

Pulmonary Hypertension2 trials

Quantifying the Presence of Lung Disease and Pulmonary Hypertension in Children With Sickle Cell Disease

Completed·—·Phase 1·NCT01895998·5 enrolled

Effect of Inhaled Albuterol in Pulmonary Hypertension

Completed·UUniversity of Miami·Phase 2·NCT03270332·10 enrolled

Cystic Fibrosis2 trials

A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis

Suspended·NNational Center for Research Resources (NCRR)·N/A·NCT00005110

Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis

Completed·UUniversity of Arizona·N/A·NCT01880723·32 enrolled

24 more indications

Pompe Disease2 trials

Safety and Efficacy of Albuterol in Individuals With Late-onset Pompe Disease

Completed·—·Phase 1/2·NCT01885936·16 enrolled

Albuterol in Individuals With Late Onset Pompe Disease (LOPD)

Completed·—·Phase 1·NCT01859624·8 enrolled

Bronchiolitis2 trials

Respiratory Impedance and Obliterative Bronchiolitis

Completed·IIRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy·N/A·NCT01255449·26 enrolled

Trial of Epinephrine and Albuterol in Bronchiolitis

Unknown status·—·N/A·NCT00114478·600 enrolled

Facioscapulohumeral Muscular Dystrophy1 trial

Randomized Study of Albuterol in Patients With Facioscapulohumeral Muscular Dystrophy

Completed·OOhio State University·N/A·NCT00004685·90 enrolled

Congenital myasthenic syndromes1 trial

Efficacy of Albuterol in the Treatment of Congenital Myasthenic Syndromes

Completed·MMayo Clinic·Phase 1·NCT01203592·21 enrolled

Side Effects1 trial

Levalbuterol Compared to Albuterol Regarding Cardiac Side Effects and Potassium Lowering Effects.

Unknown status·UUniversity of Aleppo·Phase 4·NCT05173584·30 enrolled

Dyspnea1 trial

Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes

Withdrawn·OOhio State University·Phase 4·NCT04184609

Ventilation1 trial

Effects of Noninvasive Ventilation Compared to Salbutamol

Completed·UUniversity of Nove de Julho·N/A·NCT03430505·30 enrolled

Vascular Disease1 trial

Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial

Completed·MMayo Clinic·Phase 3·NCT02885636·30 enrolled

Salmeterol1 trial

Dose-Response of Salmeterol in Children

Completed·UUniversity of Florida·Phase 4·NCT01907334·10 enrolled

Facioscapulohumeral dystrophy1 trial

Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)

Completed·FFDA Office of Orphan Products Development·N/A·NCT00027391·160 enrolled

ART1 trial

A Study of LY2216684 in Healthy Participants Receiving Albuterol or Propanolol

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01263197·48 enrolled

Oxygen Consumption1 trial

Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

Completed·—·N/A·NCT02802111·24 enrolled

Multiple Sclerosis1 trial

Treatment of Multiple Sclerosis With Copaxone and Albuterol

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00039988·40 enrolled

Primary Ciliary Dyskinesia1 trial

Functional Studies of Novel Genes Mutated in Primary Ciliary Dyskinesia II: Genotype to Phenotype

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT04901715·27 enrolled

Congestive Heart Failure1 trial

Nebulized Albuterol for Congestive Heart Failure Exacerbation

Withdrawn·UUniversity of California, San Francisco·Phase 2/3·NCT01375361

ALK1 trial

A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)

Completed· Teva logo

Teva··NCT01302587·306 enrolled

Efficacy1 trial

A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control

Unknown status·UUniversity Health Network, Toronto·Phase 4·NCT00385359·10 enrolled

Idiopathic Pulmonary Arterial Hypertension1 trial

Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension

Withdrawn·AAmerican Medical Association Foundation·Phase 2·NCT02108743

Heart1 trial

Effect of Nebulized Bronchodilators on Heart Rate

Completed·—·Phase 4·NCT01151579·89 enrolled

Oxygenation1 trial

The Effect of Nebulized Albuterol on Donor Oxygenation

Completed·VVanderbilt University Medical Center·Phase 2·NCT00310401·506 enrolled

Tics1 trial

A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers

Completed·MMannkind Corporation·Phase 1·NCT00674050·13 enrolled

MPR1 trial

Albuterol to Improve Respiratory Strength in SCI

Terminated·VVA Office of Research and Development·Phase 4·NCT02508311·1 enrolled

Exercise1 trial

Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction

Terminated·AAmphastar Pharmaceuticals, Inc.·Phase 3·NCT00634829·24 enrolled

Unspecified5 trials

Secondhand Smoke Respiratory Health Study

Active, not recruiting·UUniversity of California, San Francisco·Phase 4·NCT02797275·107 enrolled

Symbicort Onset of Action 2

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00646009·48 enrolled

The Various Effects of Gaseous Albuterol on Serum Lactate

Completed·UUniversity Medical Center of Southern Nevada·N/A·NCT02073747·28 enrolled

Show 2 more trials

Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

Unknown status·HHadassah Medical Organization·N/A·NCT00162422·150 enrolled

Symbicort Onset of Action 1

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00646620·48 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

VENTOLIN

NDA NDA018473

Jan 1, 1982

PROVENTIL

NDA NDA017559

May 7, 1982

PROVENTIL

NDA NDA017853

Jan 19, 1983

PROVENTIL

NDA NDA018062

Jul 10, 1986

VENTOLIN

NDA NDA019112

Jan 14, 1987

PROVENTIL

NDA NDA019243

Jan 16, 1987

VENTOLIN

NDA NDA019269

Jun 10, 1987

VENTOLIN

NDA NDA019621

Jul 13, 1987

PROVENTIL

NDA NDA019383

May 4, 1988

VENTOLIN ROTACAPS

NDA NDA019489

Apr 23, 1992

VENTOLIN

NDA NDA019773

Dec 23, 1992

VOLMAX

NDA NDA019604

Aug 15, 1996

PROVENTIL-HFA

NDA NDA020503

Apr 19, 2001

VENTOLIN HFA

NDA NDA020983

Apr 30, 2001

ACCUNEB

NDA NDA020949

Oct 29, 2004

PROAIR HFA

NDA NDA021457

Dec 21, 2018

PROAIR DIGIHALER

NDA NDA205636

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Albuterol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Proair HFA drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Albuterol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Albuterol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205636). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-2 Adrenergic Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

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