NCT02109406

Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD

A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	AZD2115 Dose 1	AZD 2115, Dose 1 administered as two inhalations BID
DRUG	AZD 2115, Dose 2	AZD 2115, Dose 2 administered as two inhalations BID
DRUG	Placebo MDI	Placebo MDI administered as two inhalations BID

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-04-09
• Last updated: 2020-09-02

Locations

3 sites across 1 country: United States