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NCT02040766 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
A Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 628
- Enrollment target
- 20
- Study locations
NCT02040766: Completed Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02040766 is a Phase 3 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 628 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02040766, a Phase 3 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 628 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.
Primary Outcome
Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.
Conditions Studied
Interventions
- DRUG Placebo MDI
- DRUG Beclomethasone dipropionate BAI
- DRUG Placebo BAI
- DRUG albuterol/salbutamol 90 mcg
- DRUG Beclomethasone dipropionate MDI
Study Locations (20)
California
- Teva Investigational Site 10903 - Costa Mesa
- Teva Investigational Site 10911 - Downey
- Teva Investigational Site 10901 - Huntington Beach
- Teva Investigational Site 12297 - Huntington Beach
- Teva Investigational Site 10880 - Mission Viejo
- Teva Investigational Site 10895 - Orange
- Teva Investigational Site 10924 - Paramount
- Teva Investigational Site 10910 - Rolling Hills Estates
- Teva Investigational Site 12343 - Roseville
- Teva Investigational Site 12298 - San Diego
- Teva Investigational Site 12300 - San Diego
- Teva Investigational Site 12295 - San Jose
- Teva Investigational Site 12312 - West Covina
Alabama
- Teva Investigational Site 12346 - Hoover
- Teva Investigational Site 12294 - Montgomery
Colorado
- Teva Investigational Site 10937 - Centennial
- Teva Investigational Site 10899 - Colorado Springs
Arizona
- Teva Investigational Site 10925 - Phoenix
Arkansas
- Teva Investigational Site 12349 - Little Rock
Florida
- Teva Investigational Site 10894 - Aventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2013-12 |
| Est. Completion | 2016-03 |
| Phase | Phase 3 |
What the finished NCT02040766 record still lists
NCT02040766 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Placebo MDI is the first listed.
NCT02040766 names 20 study sites across 6 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT02040766 about?
NCT02040766 is a clinical study titled "A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma". This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 yea...
What is the current status of trial NCT02040766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 628 participants. The study started on 2013-12. Estimated completion is 2016-03.
What conditions does trial NCT02040766 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02040766?
The interventions under investigation include: Placebo MDI (DRUG), Beclomethasone dipropionate BAI (DRUG), Placebo BAI (DRUG), albuterol/salbutamol 90 mcg (DRUG), Beclomethasone dipropionate MDI (DRUG).
Who is sponsoring clinical trial NCT02040766?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02040766 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02040766's enrollment target sits among peer trials
628 63rd of 374 higher than 311 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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.
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