NCT01587079CompletedPhase 2
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
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
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)
PT003 (Dose 1)
Experimental
PT003 MDI Dose 1
Intervention: PT003 (Drug)
PT003 (Dose 2)
Experimental
PT003 MDI Dose 2
Intervention: PT003 (Drug)
PT003 (Dose 3)
Experimental
PT003 MDI Dose 3
Intervention: PT003 (Drug)
PT003 (Dose 4)
Experimental
PT003 MDI Dose 4
Intervention: PT003 (Drug)
PT003 (Dose 5)
Experimental
PT003 MDI Dose 5
Intervention: PT003 (Drug)
PT005
Experimental
PT005 MDI
Intervention: PT005 (Drug)
Spiriva® Handihaler®
Active Comparator
Tiotropium Bromide
Intervention: Tiotropium inhalation powder (Drug)
Outcomes
Primary Outcomes
FEV1 AUC 0-12 on Day 7
Time Frame: Day 7
FEV1 AUC 0-12
Secondary Outcomes
- Peak Change From Baseline in FEV1 on Day 7(Day 7)
- Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7(Day 7)
- Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7(Day 7)
- Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1(Day 1)
- Peak Change From Baseline in FEV1 on Treatment Day 1(Day 1)
- Peak Change From Baseline in Inspiratory Capacity on Day 1(Day 1)
- Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7(Day 7)
- Peak Change From Baseline IC on Day 7(Day 7)
- Time to Onset of Action (>10% Improvement in FEV1) on Day 1(Day 1)
- Change From Baseline in Morning Pre-dose Trough IC on Day 7(Day 7)
- Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7(Day 7)
- Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7(Day 7)
- Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7(Day 7)
Investigators
Study Sites (1)
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