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NCT02513160 · ClinicalTrials.gov registry record · Phase 3

Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

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

Completed
Registry status
Phase 3
Development phase
713
Enrollment target

NCT02513160 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 713 participants.

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The verdict

NCT02513160, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 3
Development phase
713 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC\[0-6wk\]).

Interventions

  • DRUG Placebo
  • DRUG albuterol/salbutamol
  • DRUG Beclomethasone Dipropionate 640
  • DRUG Beclomethasone dipropionate via 320 mcg BAI
  • DRUG Beclomethasone dipropionate via 320 mcg MDI

Trial Details

FieldValue
Enrollment Target 713 participants
Start Date 2015-09-30
Est. Completion 2016-03-31
Phase Phase 3

What the Registry Record Tells You About NCT02513160

The ClinicalTrials.gov registry entry for NCT02513160 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02513160 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02513160 about?

NCT02513160 is a clinical study titled "Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma". The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standard...

What is the current status of trial NCT02513160?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 713 participants. The study started on 2015-09-30. Estimated completion is 2016-03-31.

What interventions are being tested in trial NCT02513160?

The interventions under investigation include: Placebo (DRUG), albuterol/salbutamol (DRUG), Beclomethasone Dipropionate 640 (DRUG), Beclomethasone dipropionate via 320 mcg BAI (DRUG), Beclomethasone dipropionate via 320 mcg MDI (DRUG).

Who is sponsoring clinical trial NCT02513160?

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

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.