ATROVENT HFA (ipratropium bromide)
Atrovent HFA is a bronchodilator used for the long-term management of breathing difficulties in people with chronic obstructive pulmonary disease (COPD). It helps patients with chronic bronchitis and emphysema by keeping their airways open and managing bronchospasms. Doctors prescribe this medication as a maintenance therapy to help improve airflow and make breathing easier over time.
How ATROVENT HFA Works
This medication works by blocking the action of acetylcholine, a chemical messenger that causes muscles in the lungs to tighten. By preventing acetylcholine from binding to muscarinic receptors on the smooth muscle of the airways, it stops the rise of calcium levels inside the cells. This process prevents the airways from constricting, which helps the lungs stay open.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-11-17
- Routes
- INHALATION
- Dosage Forms
- AEROSOL, METERED
ATROVENT HFA Approval History
What ATROVENT HFA Treats
4 indicationsATROVENT HFA is approved for 4 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchospasm
- Chronic Obstructive Pulmonary Disease
- Chronic Bronchitis
- Emphysema
ATROVENT 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.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07394036 | 2026-031 | Ph 2 | not yet recruiting | Effect of Ipratropium Bromide on EILO |
| NCT06074185 T-RECS results posted | 00138724 | Ph 2 | completed | Treating Respiratory Emergencies in Children Study |
| NCT04315558 RARICO | IRB#20-000129 | Ph 2 | completed | Revefenacin in Acute Respiratory Insufficiency in COPD |
| NCT01691079 STAMINA results posted | 12-09621 | Ph 4 | completed | Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes |
| NCT01943552 results posted | 244.2514 | Ph 4 | completed | Ipratropium Bromide in Peri-Operative COPD |
| NCT00911651 | PML_DOC_0801 | Ph 4 | completed | Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients |
| NCT00605410 | BIO 07-161 | Ph 4 | completed | Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness |
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.
ATROVENT HFA FDA Label Details
Indications & Usage
FDA Label (PDF)ATROVENT HFA is indicated for the treatment of Bronchospasm; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema.
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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