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NCT00988247 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
NCT00988247: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT00988247 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 529 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00988247, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
Study Summary
Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.
Primary Outcome
Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline
Interventions
- DRUG Beclomethasone dipropionate
- DRUG Placebo Nasal Aerosol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2009-10-31 |
| Est. Completion | 2011-02-28 |
| Phase | Phase 3 |
What the finished NCT00988247 record still lists
NCT00988247 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Beclomethasone dipropionate is the first listed.
NCT00988247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00988247 about?
NCT00988247 is a clinical study titled "Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis". Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is c...
What is the current status of trial NCT00988247?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2009-10-31. Estimated completion is 2011-02-28.
What interventions are being tested in trial NCT00988247?
The interventions under investigation include: Beclomethasone dipropionate (DRUG), Placebo Nasal Aerosol (DRUG).
Who is sponsoring clinical trial NCT00988247?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00988247's enrollment target sits among peer trials
529 709th of 2000 higher than 1,290 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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