PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350128
• Other study ID #: PT001002
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2011
• Est. completion date: October 1, 2011

Study information

• Verified date: May 2018
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 1, 2011
• Est. primary completion date: October 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 (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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PT001 MDI
PT001 MDI administered as two puffs BID for 7 days
• Ipratropium Bromide HFA Inhalation Aerosol
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID

Other:
• Placebo MDI
Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Charlotte	North Carolina
United States	Pearl Investigative Site	Cherry Hill	New Jersey
United States	Pearl Investigative Site	Longview	Texas
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Panama City	Florida
United States	Pearl Investigative Site	Richmond	Virginia
United States	Pearl Investigative Site	Summit	New Jersey
United States	Pearl Investigative Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 AUC0-12	FEV1 AUC0-12 following chronic dosing (1 week), normalized.	Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)
Secondary	Peak Change From Baseline in FEV1 on Day 1	Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)	Day 1
Secondary	Time to Onset of Action ( =10% Improvement in FEV1) on Day 1	Time to onset of action ( =10% improvement in FEV1)	Day 1 (15 min, 30 min, 1 hour, 2 hours)
Secondary	Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1	Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)	Day 1
Secondary	Peak Change From Baseline in IC on Day 1	Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)	Day 1
Secondary	Change From Baseline in Morning Pre-dose FEV1 on Day 7	Change from baseline in morning pre-dose FEV1	Day 7
Secondary	Peak Change From Baseline in FEV1 on Day 7	Peak change from baseline in FEV1	Day 7
Secondary	Peak Change From Baseline in IC on Day 7	Peak change from baseline in IC	Day 7
Secondary	Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7	Change from baseline in 12-hour post-dose trough FEV1	Day 7

External Links

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