PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
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: PT001 MDI (Drug); Tiotropium Bromide (Drug); PT001 Placebo MDI (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 overall objective of this study is to determine an optimal dose and dosing regimen of
PT001 MDI for further evaluation in later stage studies.
Clinical Details
Official title: A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An 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
Secondary outcome: Peak change in FEV1Time to onset of action Peak change in Inspiratory Capacity (IC)
Detailed description:
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in
subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the
range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared
to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 (or CT scan) 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, Fullerton, California 92835, United States
Pearl Investigative Site, Clearwater, Florida 33765, United States
Pearl Investigative Site, Panama City, Florida 32405, United States
Pearl Investigative Site, Tampa, Florida 33603, United States
Pearl Investigative Site, Winter Park, Florida 32789, United States
Pearl Investigative Site, Charlotte, North Carolina 28207, United States
Pearl Investigative Site, Medford, Oregon 97504, United States
Pearl Investigative Site, Spartanburg, South Carolina 29303, United States
Pearl Investigative Site, Longview, Texas 75605, United States
Pearl Investigative Site, Richmond, Virginia 23225, United States
Additional Information
Starting date: March 2012
Last updated: November 14, 2013
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