PT003 MDI Dose Confirmation Study

Phase 2

Completed

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

• Registration Number: NCT01349816
• Lead Sponsor: Pearl Therapeutics, Inc.

Brief Summary

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Study Start: 2011-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Disposition First Submitted: 2013-05-16
• Disposition First Submitted QC: 2013-05-16
• Disposition First Posted: 2013-05-24
• Results First Submitted: 2016-05-21
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-26
• Last Update Submitted: 2017-04-26
• Results First Posted: 2017-04-27
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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 (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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PT003 (Dose 3)	PT003	PT003 MDI Dose 3
PT005	PT005	PT005 MDI
PT003 (Dose 4)	PT003	PT003 MDI Dose 4
PT001	PT001	PT001 MDI
PT003 (Dose 1)	PT003	PT003 MDI Dose 1
PT003 (Dose 2)	PT003	PT003 MDI Dose 2

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-12	Day 7	Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).

Secondary Outcome Measures

Name	Time	Method
Peak Change From Baseline in IC	Day 7	Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Time to Onset of Action	Day 1	At least 10% improvement in mean FEV1
At Least 12% Improvement in FEV1	Day 1	Proportion of subjects achieving \>=12% improvement in FEV1 relative to baseline
Morning Pre-dose FEV1	Day 7	Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Peak Change From Baseline in FEV1	Day 1	Peak change from baseline in FEV1 through 2 hours
Peak Change in IC	Day 1	Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
FEV1 Through 6 Hours	Day 7	Peak change from baseline in FEV1 through 6 hours
Mean Evening Trough FEV1	Day 7	Change from baseline in mean evening 12-hour post-dose trough FEV1

Trial Locations

Locations (1)

Pearl Investigative Site; 🇺🇸 Spartanburg, South Carolina, United States