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

Pearl Therapeutics, Inc.1 site in 1 country159 target enrollmentStarted: April 2012Last updated: June 30, 2016

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: Pearl Therapeutics, Inc.
Enrollment: 159
Locations: 1
Primary Endpoint: FEV1 AUC 0-12 on Day 7

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 40 Years to 80 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Signed written informed consent
•40 - 80 years of age
•Clinical history of COPD with airflow limitation that is not fully reversible
•Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods
•Current/former smokers with at least a 10 pack-year history of cigarette smoking
•A measured post-bronchodilator FEV1/FVC ratio of < or = 0.70
•A measured post-bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
•Able to change COPD treatment as required by protocol

Exclusion Criteria

•Women who are pregnant or lactating
•Primary diagnosis of asthma
•Alpha-1 antitrypsin deficiency as the cause of COPD
•Active pulmonary diseases
•Prior lung volume reduction surgery
•Abnormal chest X-ray not due to the presence of COPD
•Hospitalized due to poorly controlled COPD within 3 months of Screening
•Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
•Cancer that has not been in complete remission for at least 5 years
•Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
•Other inclusion/exclusion criteria as defined in the protocol

Arms & Interventions

PT001

Experimental

PT001 MDI

Intervention: PT001 (Drug)