NCT02268396

Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

An Open-Label, Multi-Center, Dose Indicator Study of Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) in Adult Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler	GFF MDI administered as 2 inhalations BID

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-01-01
• Completion: 2015-05-01
• First posted: 2014-10-20
• Last updated: 2016-12-23
• Results posted: 2016-12-23

Locations

10 sites across 1 country: United States