Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: PT003; Drug: PT001; Drug: PT005; Drug: Tiotropium inhalation powder

• Registration Number: NCT01587079
• Lead Sponsor: Pearl Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-27
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Disposition First Submitted: 2013-10-22
• Disposition First Submitted QC: 2013-10-22
• Disposition First Posted: 2013-11-14
• Status Verified: 2016-05
• Results First Submitted: 2016-05-23
• Results First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Results First Posted: 2016-06-30
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PT003 (Dose 2)	PT003	PT003 MDI Dose 2
PT003 (Dose 1)	PT003	PT003 MDI Dose 1
PT001	PT001	PT001 MDI
PT005	PT005	PT005 MDI
PT003 (Dose 4)	PT003	PT003 MDI Dose 4
Spiriva® Handihaler®	Tiotropium inhalation powder	Tiotropium Bromide
PT003 (Dose 3)	PT003	PT003 MDI Dose 3
PT003 (Dose 5)	PT003	PT003 MDI Dose 5

Primary Outcome Measures

Name	Time	Method
FEV1 AUC 0-12 on Day 7	Day 7	FEV1 AUC 0-12

Secondary Outcome Measures

Name	Time	Method
Peak Change From Baseline in FEV1 on Day 7	Day 7	Peak change from baseline in FEV1 Day 7
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	Day 7	Change from baseline at evening 12-hour post-dose trough FEV1
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	Day 1	Proportion of subjects achieving \>=12% improvement in FEV1
Peak Change From Baseline in FEV1 on Treatment Day 1	Day 1	Peak change from Baseline in FEV1 on Treatment
Peak Change From Baseline in Inspiratory Capacity on Day 1	Day 1	Peak change from baseline in Inspiratory Capacity
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	Day 7	Change from baseline in morning pre-dose trough FEV1
Peak Change From Baseline IC on Day 7	Day 7	Peak change from baseline IC
Time to Onset of Action (>10% Improvement in FEV1) on Day 1	Day 1	Time to onset of action (\>10% improvement in FEV1)
Change From Baseline in Morning Pre-dose Trough IC on Day 7	Day 7	Change from baseline in morning pre-dose trough IC
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean morning post-dose daily peak flow readings on
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean morning pre-dose daily peak flow readings
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)

Trial Locations

Locations (1)

Pearl Investigative Site; 🇺🇸 Morgantown, West Virginia, United States