At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 405 enrolled
Drug / intervention
Albuterol sulfate (ABS)drug
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.
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 (40 Years of Age or Older) With Chronic Obstructive Pulmonary Disease
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Aug 22, 2017·Updated Nov 9, 2021
In Brief
A Phase 3 clinical trial evaluating Albuterol sulfate (ABS) for Chronic Obstructive Pulmonary Disease. Completed, enrolled 405 participants across 40 sites.
Detailed Summary
This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionApr 2018
TodayJul 2026
First PostedAug 22, 2017
Enrollment StartSep 28, 2017
Primary CompletionApr 17, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.9 years ago
Interventions
Albuterol sulfate (ABS)drug
ABS will be administered via eMDPI as per the dose and schedule specified in the arm.