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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: September 11, 2012
Last verified: September 2012
History of Changes

March 9, 2010
September 11, 2012
March 2010
November 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Day 7 time points for FEV1 are measured over 12 hours
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 ] [ Designated as safety issue: No ]
Day 7 time points for FEV1 are measured over 12 hrs
Complete list of historical versions of study NCT01085045 on ClinicalTrials.gov Archive Site
  • Peak FEV1, time to onset of action (greater than or equal to 10% improvement in mean FEV1), proportion of patients with greater than or equal to 12% improvement in FEV1 and peak improvement in inspiratory capacity (IC) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 timepoints for FEV1 and IC are measured over 2 hours
  • Improvement in pre-dose FEV1, peak FEV1, peak improvement in IC, and trough FEV1 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Day 7 time points for FEV1 are measured over 12 hours
  • Mean daily peak expiratory flow rate [ Time Frame: Day 1 through Day 7 ] [ Designated as safety issue: No ]
  • Lung function measures [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Throughout the study period
Not Provided
Not Provided
 
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)
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   New Zealand
 
NCT01085045
PT0031002
No
Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
Not Provided
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
September 2012

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