Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pearl Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT01085045

First received: March 9, 2010

Last updated: March 14, 2017

Last verified: March 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2010

Last Updated Date

March 14, 2017

Start Date ^ICMJE

March 2010

Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

FEV1 AUC 0-12 on Day 7 [ Time Frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7 ]

Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration

Original Primary Outcome Measures ^ICMJE

Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline [ Time Frame: Day 7 ]

Day 7 time points for FEV1 are measured over 12 hrs

Change History

Complete list of historical versions of study NCT01085045 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Peak Change From BL in FEV1 on Day 1 [ Time Frame: Day 1 ]
Peak change from Baseline in FEV1 on Day 1
Peak Change From BL in FEV1 on Day 7 [ Time Frame: Day 7 ]
Peak change from Baseline (BL) in FEV1 on Day 7
Peak Change From BL in Inspiratory Capacity on Day 1 [ Time Frame: Day 1 ]
Peak change from Baseline in Inspiratory Capacity (IC) on Day 1
Peak Change From BL IC on Day 7 [ Time Frame: Day 7 ]
Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration
Time to Onset of Action >=10% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]
Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%
Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]
Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%
Change in Morning Pre-dose FEV1 on Day 7 [ Time Frame: Day 7 ]
Change from Baseline in morning pre-dose FEV1 on Day 7
12 hr Post-dose Trough FEV1 on Day 7 [ Time Frame: Day 7 ]
12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7
Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]
Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7
Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]
Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7
Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]
Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7
Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7 [ Time Frame: Day 7 ]
Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7

Original Secondary Outcome Measures ^ICMJE

Lung function measures [ Time Frame: Day 7 ]
Day 7 lung function is measured over 12 hrs
Safety measures including electrocardiograms (ECGs), vital signs, adverse events, tremors and dry mouth assessments, and clinical laboratory tests [ Time Frame: Throughout the study period ]
Throughout the study period

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Official Title ^ICMJE

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

Brief Summary

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

Drug: PT003 MDI
Inhaled PT003 MDI administered as two puffs BID for 7 days
Drug: PT005 MDI
Inhaled PT005 MDI administered as two puffs BID for 7 days
Drug: Placebo MDI
Inhaled placebo administered as two puffs BID for 7 days
Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
Drug: PT001 MDI
Inhaled PT001 MDI administered as two puffs BID for 7 days

Study Arms

Experimental: Inhaled PT003 (Dose 1)
PT003 MDI Dose 1

Intervention: Drug: PT003 MDI
Experimental: Inhaled PT003 (Dose 2)
PT003 MDI Dose 2

Intervention: Drug: PT003 MDI
Experimental: Inhaled PT005 (Dose 1)
PT005 MDI Dose 1

Intervention: Drug: PT005 MDI
Experimental: Inhaled PT005 (Dose 2)
PT005 MDI Dose 2

Intervention: Drug: PT005 MDI
Placebo Comparator: Inhaled Placebo
Placebo MDI

Intervention: Drug: Placebo MDI
Active Comparator: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Tiotropium Bromide inhalation powder

Intervention: Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg

Intervention: Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Experimental: Inhaled PT001 (Dose 1)
PT001 MDI Dose 1

Intervention: Drug: PT001 MDI

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

118

Completion Date

November 2010

Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 protocol defined inclusion/exclusion criteria may apply

Sex/Gender

Sexes Eligible for Study:

All

Ages

40 Years to 80 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Australia, New Zealand

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01085045

Other Study ID Numbers ^ICMJE

PT0031002

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Pearl Therapeutics, Inc.

Study Sponsor ^ICMJE

Pearl Therapeutics, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Colin Reisner, M.D.

Pearl Therapeutics, Inc.

Information Provided By

Pearl Therapeutics, Inc.

Verification Date

March 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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