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

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ClinicalTrials.gov Identifier: NCT01350128
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : June 8, 2017
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: PT001 MDI Drug: Ipratropium Bromide HFA Inhalation Aerosol Other: Placebo MDI Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2011
Actual Primary Completion Date : October 1, 2011
Actual Study Completion Date : October 1, 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PT001 MDI (Dose 1)
PT001 MDI
 Drug: PT001 MDI
PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 2)
PT001 MDI
 Drug: PT001 MDI
PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 3)
PT001 MDI
 Drug: PT001 MDI
PT001 MDI administered as two puffs BID for 7 days
Experimental: PT001 MDI (Dose 4)
PT001 MDI
 Drug: PT001 MDI
PT001 MDI administered as two puffs BID for 7 days
Active Comparator: Ipratropium Bromide HFA Inhalation Aerosol
Ipratropium Bromide HFA Inhalation Aerosol
 Drug: Ipratropium Bromide HFA Inhalation Aerosol
Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
Other Name: Atrovent
Placebo Comparator: Placebo MDI
PT001 Placebo MDI
 Other: Placebo MDI
Matching placebo to PT001 MDI administered as two puffs BID for 7 days


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Change From Baseline in Morning Pre-dose FEV1 on Day 7 [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose FEV1

  6. Peak Change From Baseline in FEV1 on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline in FEV1

  7. Peak Change From Baseline in IC on Day 7 [ Time Frame: Day 7 ]
    Peak change from baseline in IC

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350128


Locations
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United States, Florida
Pearl Investigative Site
Panama City, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
United States, New Jersey
Pearl Investigative Site
Cherry Hill, New Jersey, United States
Pearl Investigative Site
Summit, New Jersey, United States
United States, North Carolina
Pearl Investigative Site
Charlotte, North Carolina, United States
United States, Oregon
Pearl Investigative Site
Medford, Oregon, United States
United States, Texas
Pearl Investigative Site
Longview, Texas, United States
United States, Virginia
Pearl Investigative Site
Richmond, Virginia, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01350128    
Other Study ID Numbers: PT001002
First Posted: May 9, 2011    Key Record Dates
Results First Posted: June 8, 2017
Last Update Posted: June 20, 2018
Last Verified: May 2018
Keywords provided by Pearl Therapeutics, Inc.:
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action