NCT02969408

A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Albuterol Sulfate	Albuterol sulfate will be administered as per the dose and schedule specified in the arm.

Timeline

• Start date: 2017-02-13
• Primary completion: 2018-02-02
• Completion: 2018-02-02
• First posted: 2016-11-21
• Last updated: 2021-11-09
• Results posted: 2019-05-03

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated drug study