NCT03256695

Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 405 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Albuterol sulfate (ABS)	ABS will be administered via eMDPI as per the dose and schedule specified in the arm.

Timeline

• Start date: 2017-09-28
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2017-08-22
• Last updated: 2021-11-09
• Results posted: 2019-08-06

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study