PROAIR HFA (albuterol sulfate)
ProAir HFA helps patients aged four and older manage reversible obstructive airway disease by treating or preventing bronchospasm. It is also used to prevent breathing difficulties that occur specifically during physical activity. This medication provides relief by relaxing the muscles in the airways to improve airflow.
How PROAIR HFA Works
This medication works by activating beta 2-adrenergic receptors in the lungs, which triggers an increase in cyclic AMP and lowers calcium levels within the cells. This process results in the relaxation of smooth muscles throughout the entire respiratory tract, from the trachea to the terminal bronchioles. Additionally, the drug helps inhibit the release of inflammatory mediators from mast cells in the airway.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-10-29
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
PROAIR HFA Approval History
What PROAIR HFA Treats
2 indicationsPROAIR HFA is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Obstructive Airway Disease
PROAIR HFA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PROAIR HFA
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07426458 | 20251152 | Ph 4 | recruiting | Ventilation and Perfusion in Asthmatics |
| NCT06052267 | FpA-AS-30094 2023-505435-12-00 | Ph 3 | recruiting | A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations |
| NCT05035862 | STUDY00002655 2709 | Ph 1 | terminated | Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma |
| NCT01899144 results posted | ABS-AS-202 | Ph 2 | completed | Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients |
| NCT02969408 results posted | ABS-AS-30064 | Ph 3 | completed | A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma |
| NCT03586544 results posted | 1131374-2 | Ph 4 | terminated | Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT02584257 results posted | AS-MDI-301 | Ph 3 | completed | Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma |
| NCT02566252 | PUL-042-003 | Ph 1 | completed | Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PROAIR HFA FDA Label Details
Indications & Usage
FDA Label (PDF)PROAIR HFA is indicated for the treatment of Bronchospasm; Obstructive Airway Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment