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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 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.

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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.

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

FieldValue
Enrollment Target 628 participants
Start Date 2013-12
Est. Completion 2016-03
Phase Phase 3

What the Registry Record Tells You About NCT02040766

The ClinicalTrials.gov registry entry for NCT02040766 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (60% lower). The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.