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 23, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: PT001 MDI
Drug: Ipratropium Bromide HFA Inhalation Aerosol
Other: Placebo MDI
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:
  • FEV1 AUC0-12 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    FEV1 AUC0-12 relative to baseline following chronic dosing (1 week).


Secondary Outcome Measures:
  • Peak change in FEV1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Highest value of FEV1 post-dose on Day 1

  • Time to onset of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Time to reach ≥10% improvement on Day 1

  • Peak improvement in Inspiratory Capacity (IC) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Peak improvement in inspiratory capacity on Day 1


Enrollment: 103
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350128

Locations
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
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01350128     History of Changes
Other Study ID Numbers: PT001002
Study First Received: May 5, 2011
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bromides
Ipratropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on April 14, 2014