PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01566773
First received: March 27, 2012
Last updated: November 14, 2013
Last verified: November 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: Tiotropium Bromide
Drug: PT001 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 (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, 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: 14 days ] [ Designated as safety issue: No ]
    Forced expiratory volume in 1 second area under the curve (FEV1 AUC0-12) relative to baseline following chronic dosing (14 days).


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 change in Inspiratory Capacity (IC) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline


Enrollment: 140
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PT001 MDI (Dose 1) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 2) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 3) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 4) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 5) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Experimental: PT001 MDI (Dose 6) Drug: PT001 MDI
Administered as two puffs BID for 14 days
Placebo Comparator: PT001 Placebo MDI Drug: PT001 Placebo MDI
Active Comparator: Spiriva® Handihaler® (Tiotropium Bromide) Drug: Tiotropium Bromide
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
Other Name: Spiriva® Handihaler®

Detailed Description:

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP 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

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 inclusion/exclusion criteria as defined in the protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566773

Locations
United States, California
Pearl Investigative Site
Fullerton, California, United States, 92835
United States, Florida
Pearl Investigative Site
Clearwater, Florida, United States, 33765
Pearl Investigative Site
Panama City, Florida, United States, 32405
Pearl Investigative Site
Tampa, Florida, United States, 33603
Pearl Investigative Site
Winter Park, Florida, United States, 32789
United States, North Carolina
Pearl Investigative Site
Charlotte, North Carolina, United States, 28207
United States, Oregon
Pearl Investigative Site
Medford, Oregon, United States, 97504
United States, South Carolina
Pearl Investigative Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Pearl Investigative Site
Longview, Texas, United States, 75605
United States, Virginia
Pearl Investigative Site
Richmond, Virginia, United States, 23225
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, MD Pearl Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01566773     History of Changes
Other Study ID Numbers: PT001003
Study First Received: March 27, 2012
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pearl Therapeutics, Inc.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014