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Placebo breath-actuated inhaler
A placebo inhaler device that delivers no active pharmaceutical ingredient, used as a control comparator in clinical trials.
A placebo inhaler device that delivers no active pharmaceutical ingredient, used as a control comparator in clinical trials. Used for Clinical trial control/comparator (not a therapeutic indication).
At a glance
| Generic name | Placebo breath-actuated inhaler |
|---|---|
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
This is a breath-actuated inhaler device formulated without any active drug substance, designed to match the physical and sensory characteristics of an active comparator inhaler. It is used in Phase 3 clinical trials to provide a placebo control arm, allowing researchers to isolate the therapeutic effect of an active treatment from placebo response and device-related effects.
Approved indications
- Clinical trial control/comparator (not a therapeutic indication)
Common side effects
Key clinical trials
- Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR® (PHASE1)
- Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418) (PHASE4)
- Single Ascending Dose and Multiple Ascending Dose Study of Niclosamide Inhalation Powder in Healthy Adult Subjects (PHASE1)
- Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma (PHASE3)
- Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma (PHASE1)
- A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma (PHASE3)
- A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma (PHASE3)
- A Study of 3 Doses of Tiotropium Hydrofluoralkane (HFA) Breath Actuated Inhaler (BAI), in Patients With Chronic Obstructive Pulmonary Disease (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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