CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
Albuterol Sulfatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02969408
NCT02969408Phase 3Completed
CompareCT.gov

A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (18 Years of Age or Older) With Asthma

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Nov 21, 2016·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Albuterol Sulfate for Asthma. Completed, enrolled 397 participants across 44 sites.

Detailed Summary

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 21, 2016
Enrollment StartFeb 13, 2017
Primary CompletionFeb 2, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 9.6 years ago

Interventions

Albuterol Sulfatedrug

Albuterol sulfate will be administered as per the dose and schedule specified in the arm.