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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01350128
First received: May 5, 2011
Last updated: May 8, 2017
Last verified: April 2017
May 5, 2011
May 8, 2017
May 2011
October 2011   (Final data collection date for primary outcome measure)
FEV1 AUC0-12 [ Time Frame: 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) ]
FEV1 AUC0-12 following chronic dosing (1 week), normalized.
FEV1 AUC0-12 [ Time Frame: 7 days ]
FEV1 AUC0-12 relative to baseline following chronic dosing (1 week).
Complete list of historical versions of study NCT01350128 on ClinicalTrials.gov Archive Site
  • Peak Change From Baseline in FEV1 on Day 1 [ Time Frame: Day 1 ]
    Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)
  • Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1 [ Time Frame: Day 1 (15 min, 30 min, 1 hour, 2 hours) ]
    Time to onset of action ( ≥10% improvement in FEV1)
  • Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1 [ Time Frame: Day 1 ]
    Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)
  • Peak Change From Baseline in IC on Day 1 [ Time Frame: 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)
  • Change From Baseline in Morning Pre-dose FEV1 on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose FEV1
  • Peak Change From Baseline in FEV1 on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline in FEV1
  • Peak Change From Baseline in IC on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline in IC
  • Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in 12-hour post-dose trough FEV1
  • Peak change in FEV1 [ Time Frame: Day 1 ]
    Highest value of FEV1 post-dose on Day 1
  • Time to onset of action [ Time Frame: Day 1 ]
    Time to reach ≥10% improvement on Day 1
  • Peak improvement in Inspiratory Capacity (IC) [ Time Frame: Day 1 ]
    Peak improvement in inspiratory capacity on Day 1
Not Provided
Not Provided
 
PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: PT001 MDI
    PT001 MDI administered as two puffs BID for 7 days
  • Drug: Ipratropium Bromide HFA Inhalation Aerosol
    Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
    Other Name: Atrovent
  • Other: Placebo MDI
    Matching placebo to PT001 MDI administered as two puffs BID for 7 days
  • Experimental: PT001 MDI (Dose 1)
    PT001 MDI
    Intervention: Drug: PT001 MDI
  • Experimental: PT001 MDI (Dose 2)
    PT001 MDI
    Intervention: Drug: PT001 MDI
  • Experimental: PT001 MDI (Dose 3)
    PT001 MDI
    Intervention: Drug: PT001 MDI
  • Experimental: PT001 MDI (Dose 4)
    PT001 MDI
    Intervention: Drug: PT001 MDI
  • Active Comparator: Ipratropium Bromide HFA Inhalation Aerosol
    Ipratropium Bromide HFA Inhalation Aerosol
    Intervention: Drug: Ipratropium Bromide HFA Inhalation Aerosol
  • Placebo Comparator: Placebo MDI
    PT001 Placebo MDI
    Intervention: Other: Placebo MDI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
October 2011
October 2011   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01350128
PT001002
No
Not Provided
Not Provided
Not Provided
Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
Not Provided
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
April 2017

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