Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 following chronic dosing (7 Days) in Patients with Moderate to Very Severe chronic obstructive pulmonary disease (COPD)

Study identifier:PT0031002

ClinicalTrials.gov identifier:NCT01085045

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

No

Study drug

PT003 MDI, PT005 MDI, Placebo MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®), Formoterol Fumarate 12 μg (Foradil® Aerolizer®), PT001 MDI

Sex

All

Actual Enrollment

118

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Mar 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2018 by Pearl Therapeutics, Inc.

Sponsors

Pearl Therapeutics, Inc.

Collaborators

-

Inclusion and exclusion criteria