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NCT02031640 · 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 >=12 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
1,113
Enrollment target
20
Study locations

NCT02031640: Completed Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT02031640 is a Phase 3 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 1,113 participants, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02031640, a Phase 3 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
1,113 participants
Enrollment target
20
Study locations

Study Summary

This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Primary Outcome

Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). 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 FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) wa

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Albuterol/salbutamol
  • DRUG Beclomethasone dipropionate

Study Locations (20)

California

  • Teva Investigational Site 10851 - Costa Mesa
  • Teva Investigational Site 10849 - Huntington Beach
  • Teva Investigational Site 10872 - Huntington Beach
  • Teva Investigational Site 10833 - Long Beach
  • Teva Investigational Site 10861 - Los Angeles
  • Teva Investigational Site 10798 - Mission Viejo
  • Teva Investigational Site 10806 - Orange
  • Teva Investigational Site 10828 - Orange
  • Teva Investigational Site 10860 - Paramount
  • Teva Investigational Site 10813 - Rancho Mirage
  • Teva Investigational Site 10843 - Riverside
  • Teva Investigational Site 10857 - Rolling Hills Estates
  • Teva Investigational Site 10847 - San Diego
  • Teva Investigational Site 10871 - San Diego
  • Teva Investigational Site 10876 - San Jose
  • Teva Investigational Site 12270 - Walnut Creek

Colorado

  • Teva Investigational Site 12266 - Centennial
  • Teva Investigational Site 10838 - Colorado Springs
  • Teva Investigational Site 10844 - Denver
  • Teva Investigational Site 10799 - Wheat Ridge

Trial Details

FieldValue
Enrollment Target 1,113 participants
Start Date 2013-12
Est. Completion 2014-12
Phase Phase 3

What the finished NCT02031640 record still lists

NCT02031640 is an interventional study that assigns participants to a tested intervention. Its 1,113 participants enrollment target places it among the larger protocols in the corpus, below the 1,560-participant average among 374 other Asthma trials with a reported enrollment target (29% lower).

The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02031640 names 20 study sites across 2 states, led by California, Colorado.

Frequently Asked Questions

What is clinical trial NCT02031640 about?

NCT02031640 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 >=12 Years Old With Persistent Asthma". This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

What is the current status of trial NCT02031640?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,113 participants. The study started on 2013-12. Estimated completion is 2014-12.

What conditions does trial NCT02031640 study?

This clinical trial studies the following conditions: Asthma.

What interventions are being tested in trial NCT02031640?

The interventions under investigation include: Placebo (DRUG), Albuterol/salbutamol (DRUG), Beclomethasone dipropionate (DRUG).

Who is sponsoring clinical trial NCT02031640?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02031640 being conducted?

This trial has 20 study locations across California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02031640's enrollment target sits among peer trials

1,113 34th of 374 higher than 341 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02031640, the US trial registry maintained by the National Library of Medicine. NCT02031640 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.