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NCT02040779 · ClinicalTrials.gov registry record · Phase 3

A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 3
Development phase
273
Enrollment target

NCT02040779: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT02040779 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 273 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02040779, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
273 participants
Enrollment target

Study Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Primary Outcome

The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. The least-square (LS) means, difference of LS means a

Interventions

  • DRUG albuterol/salbutamol
  • DRUG Beclomethasone dipropionate breath-actuated inhaler
  • DRUG Placebo breath-actuated inhaler

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2013-12-26
Est. Completion 2014-12-24
Phase Phase 3

What the finished NCT02040779 record still lists

NCT02040779 is an interventional study that assigns participants to a tested intervention. The registered 273 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 (65% lower).

The record links to 0 conditions, and to 3 interventions - of which albuterol/salbutamol is the first listed.

NCT02040779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02040779 about?

NCT02040779 is a clinical study titled "A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma". This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after ...

What is the current status of trial NCT02040779?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 273 participants. The study started on 2013-12-26. Estimated completion is 2014-12-24.

What interventions are being tested in trial NCT02040779?

The interventions under investigation include: albuterol/salbutamol (DRUG), Beclomethasone dipropionate breath-actuated inhaler (DRUG), Placebo breath-actuated inhaler (DRUG).

Who is sponsoring clinical trial NCT02040779?

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

How this trial's enrollment target compares

Where NCT02040779's enrollment target sits among peer trials

273 1213th of 2000 higher than 787 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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Source: ClinicalTrials.gov NCT02040779, the US trial registry maintained by the National Library of Medicine. NCT02040779 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.