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
Public ClinicalTrials.gov record NCT02040766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age With Persistent Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02040766
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 628 participants
Conditions and interventions
Conditions
Interventions
- Beclomethasone dipropionate BAI Drug
- Placebo BAI Drug
- albuterol/salbutamol 90 mcg Drug
- Beclomethasone dipropionate MDI Drug
- Placebo MDI Drug
Drug
Eligibility (public fields only)
- Age range
- 4 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2013 (Type not available)
- Primary completion
- Feb 2016 (Actual)
- Completion
- Mar 2016 (Actual)
- Last update posted
- Nov 9, 2021
2013 – 2016
United States locations
- U.S. sites
- 75
- U.S. states
- 27
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 12346 | Hoover | Alabama | — | — |
| Teva Investigational Site 12294 | Montgomery | Alabama | — | — |
| Teva Investigational Site 10925 | Phoenix | Arizona | — | — |
| Teva Investigational Site 12349 | Little Rock | Arkansas | — | — |
| Teva Investigational Site 10903 | Costa Mesa | California | — | — |
| Teva Investigational Site 10911 | Downey | California | — | — |
| Teva Investigational Site 10901 | Huntington Beach | California | — | — |
| Teva Investigational Site 12297 | Huntington Beach | California | — | — |
| Teva Investigational Site 10880 | Mission Viejo | California | — | — |
| Teva Investigational Site 10895 | Orange | California | — | — |
| Teva Investigational Site 10924 | Paramount | California | — | — |
| Teva Investigational Site 10910 | Rolling Hills Estates | California | — | — |
| Teva Investigational Site 12343 | Roseville | California | — | — |
| Teva Investigational Site 12298 | San Diego | California | — | — |
| Teva Investigational Site 12300 | San Diego | California | — | — |
| Teva Investigational Site 12295 | San Jose | California | — | — |
| Teva Investigational Site 12312 | West Covina | California | — | — |
| Teva Investigational Site 10937 | Centennial | Colorado | — | — |
| Teva Investigational Site 10899 | Colorado Springs | Colorado | — | — |
| Teva Investigational Site 10894 | Aventura | Florida | — | — |
| Teva Investigational Site 12335 | Gainesville | Florida | — | — |
| Teva Investigational Site 12336 | Homestead | Florida | — | — |
| Teva Investigational Site 12345 | Homestead | Florida | — | — |
| Teva Investigational Site 12315 | Miami | Florida | — | — |
| Teva Investigational Site 12341 | Miami | Florida | — | — |
| Teva Investigational Site 12342 | Miami | Florida | — | — |
| Teva Investigational Site 10919 | Orlando | Florida | — | — |
| Teva Investigational Site 12281 | Sarasota | Florida | — | — |
| Teva Investigational Site 12332 | Winter Park | Florida | — | — |
| Teva Investigational Site 10935 | Gainesville | Georgia | — | — |
| Teva Investigational Site 10912 | Lawrenceville | Georgia | — | — |
| Teva Investigational Site 10927 | Savannah | Georgia | — | — |
| Teva Investigational Site 10885 | Owensboro | Kentucky | — | — |
| Teva Investigational Site 12317 | Covington | Louisiana | — | — |
| Teva Investigational Site 12296 | Baltimore | Maryland | — | — |
| Teva Investigational Site 12323 | White Marsh | Maryland | — | — |
| Teva Investigational Site 10897 | North Dartmouth | Massachusetts | — | — |
| Teva Investigational Site 10932 | Ypsilanti | Michigan | — | — |
| Teva Investigational Site 10914 | Plymouth | Minnesota | — | — |
| Teva Investigational Site 10917 | Columbia | Missouri | — | — |
| Teva Investigational Site 10916 | Rolla | Missouri | — | — |
| Teva Investigational Site 12331 | Missoula | Montana | — | — |
| Teva Investigational Site 10922 | Brick | New Jersey | — | — |
| Teva Investigational Site 10909 | Ocean City | New Jersey | — | — |
| Teva Investigational Site 12289 | Verona | New Jersey | — | — |
| Teva Investigational Site 10939 | Asheville | North Carolina | — | — |
| Teva Investigational Site 12348 | Charlotte | North Carolina | — | — |
| Teva Investigational Site 10893 | Raleigh | North Carolina | — | — |
| Teva Investigational Site 10888 | Canton | Ohio | — | — |
| Teva Investigational Site 12302 | Fairfield | Ohio | — | — |
| Teva Investigational Site 10921 | Toledo | Ohio | — | — |
| Teva Investigational Site 12285 | Toledo | Ohio | — | — |
| Teva Investigational Site 10906 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 10915 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 12314 | Oklahoma City | Oklahoma | — | — |
| Teva Investigational Site 10891 | Tulsa | Oklahoma | — | — |
| Teva Investigational Site 10892 | Medford | Oregon | — | — |
| Teva Investigational Site 10898 | Portland | Oregon | — | — |
| Teva Investigational Site 12273 | Pittsburgh | Pennsylvania | — | — |
| Teva Investigational Site 12282 | Warwick | Rhode Island | — | — |
| Teva Investigational Site 10902 | North Charleston | South Carolina | — | — |
| Teva Investigational Site 10938 | Orangeburg | South Carolina | — | — |
| Teva Investigational Site 12347 | Beaumont | Texas | — | — |
| Teva Investigational Site 10926 | Boerne | Texas | — | — |
| Teva Investigational Site 10908 | Dallas | Texas | — | — |
| Teva Investigational Site 10918 | Dallas | Texas | — | — |
| Teva Investigational Site 12291 | El Paso | Texas | — | — |
| Teva Investigational Site 12329 | Live Oak | Texas | — | — |
| Teva Investigational Site 10890 | New Braunfels | Texas | — | — |
| Teva Investigational Site 10904 | San Antonio | Texas | — | — |
| Teva Investigational Site 10929 | San Antonio | Texas | — | — |
| Teva Investigational Site 10879 | Waco | Texas | — | — |
| Teva Investigational Site 10883 | Richmond | Virginia | — | — |
| Teva Investigational Site 10886 | Bellingham | Washington | — | — |
| Teva Investigational Site 10913 | Greenfield | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02040766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 9, 2021 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02040766 live on ClinicalTrials.gov.