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NCT03562949
A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol
Phase 3 trial testing Test Product in Asthma in 761 participants. Terminated before completion.
2 August 2019
Quick facts
| Lead sponsor | Amneal Ireland Limited |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 761 |
| Start date | 6 December 2018 |
| Primary completion | 2 August 2019 |
| Estimated completion | 2 August 2019 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Test Product — full drug profile →
- Reference Product — full drug profile →
- Placebo
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
Amneal Ireland Limited — full company profile →
Who can join
Adults 18 to 70, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03562949
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT04051710 — Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH · Phase 3 · completed
Other recruiting trials for Asthma
Currently open trials in the same condition.
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- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03562949 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amneal Ireland Limited
- Last refreshed: 13 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03562949.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing