Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Information source: Pearl Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: PT003 (Drug); PT001 (Drug); PT005 (Drug); Tiotropium inhalation powder (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pearl Therapeutics, Inc. Official(s) and/or principal investigator(s): Colin Reisner, MD, Study Director, Affiliation: Pearl Therapeutics, Inc.
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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: FEV1 AUC0-12
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Key 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
Key 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
Locations and Contacts
Pearl Investigative Site, Glendale, Arizona, United States
Pearl Investigative Site, Rancho Mirage, California, United States
Pearl Investigative Site, Waterbury, Connecticut, United States
Pearl Investigative Site, Clearwater, Florida 33765, United States
Pearl Investigative Site, Clearwater, Florida, United States
Pearl Investigative Site, Pensacola, Florida, United States
Pearl Investigative Site, Winter Park, Florida 32789, United States
Pearl Investigative Site, Lafayette, Louisiana, United States
Pearl Investigative Site, North Dartmouth, Massachusetts, United States
Pearl Investigative Site, Fridley, Minnesota, United States
Pearl Investigative Site, St. Louis, Missouri, United States
Pearl Investigative Site, Summit, New Jersey, United States
Pearl Investigative Site, Cincinnati, Ohio, United States
Pearl Investigative Site, Medford, Oregon 97504, United States
Pearl Investigative Site, Medford, Oregon, United States
Pearl Investigative Site, Rock Hill, South Carolina, United States
Pearl Investigative Site, Spartanburg, South Carolina 29303, United States
Pearl Investigative Site, San Antonio, Texas, United States
Pearl Investigative Site, Morgantown, West Virginia, United States
Additional Information
Starting date: April 2012
Last updated: October 22, 2013
|