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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566773
First Posted: March 29, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr) ]
    Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.


Secondary Outcome Measures:
  • Peak Change From Baseline in FEV1 [ Time Frame: Day 1 ]
    Highest value of FEV1 post dose on day 1

  • Time to Onset of Action (>10% Improvement in FEV1) on Day 1 [ Time Frame: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs) ]
    Time to Onset of Action (>10% Improvement in FEV1) on Day 1.

  • Percentage of Subjects Achieving at Least 12% Improvement in FEV1 [ Time Frame: Day 1 ]
    Percentage of subjects achieving at least 12% improvement in FEV1.

  • Peak Change From Baseline in Inspiratory Capacity (IC) [ Time Frame: Day 1 (1 hr and 2 hr post-dose ) ]
    Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline

  • Change From Baseline in Morning Pre-dose Trough FEV1 [ Time Frame: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline) ]
    Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)

  • Peak Change From Baseline in FEV1 [ Time Frame: Day 7 ]
    Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

  • Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC) [ Time Frame: Day 7 ]
    Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

  • Peak Change From Baseline in IC [ Time Frame: Day 7 (mean of 1 hr and 2 hr post-dose assessments) ]
    Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)

  • Change From Baseline in Mean Morning Pre-dose Daily PEFR [ Time Frame: Day 7 (60 minutes pre-dose, 30 minutes pre-dose) ]
    Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])

  • Change From Baseline in Morning Post-dose Daily PEFR [ Time Frame: Day 7 (30 minutes post-dose) ]
    Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])

  • Change From Baseline in Mean Evening Pre-dose PEFR [ Time Frame: Day 7 ]
    Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

  • Change From Baseline in Mean Evening Post-dose PEFR [ Time Frame: Day 7 ]
    Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)

  • Mean Number of Puffs of Rescue Medication [ Time Frame: Day 7 ]
    Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

  • Change From Baseline in Morning Pre-dose Trough FEV1 [ Time Frame: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline) ]
    Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)

  • Peak Change From Baseline in FEV1 [ Time Frame: Day 14 ]
    Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)

  • Change From Baseline for Mean Morning Pre-dose Trough IC [ Time Frame: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline) ]
    Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)

  • Peak Change From Baseline in IC [ Time Frame: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline) ]
    Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)

  • Change From Baseline in 12-hour Post-dose Trough FEV1 [ Time Frame: Day 14 (Baseline, 11.5 and 12 hours post dose) ]
    12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline

  • Change From Baseline in Mean Morning Pre-dose Daily PEFR [ Time Frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) ]
    Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]

  • Change From Baseline in Mean Morning Post-dose Daily PEFR [ Time Frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) ]
    Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]

  • Change From Baseline in Mean Evening Pre-dose Daily PEFR [ Time Frame: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7) ]
    Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

  • Change From Baseline in Mean Evening Post-dose Daily PEFR [ Time Frame: Through the end of the 14-Day Treatment ]
    Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)

  • Mean Number of Puffs of Rescue Medication (End of Treatment) [ Time Frame: Day 14 (End of treatment) ]
    Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated

  • Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14 [ Time Frame: Day 1 through Day 14 ]
    Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01566773     History of Changes
Other Study ID Numbers: PT001003
First Submitted: March 27, 2012
First Posted: March 29, 2012
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Pearl Therapeutics, Inc.:
COPD

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