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Completed

NCT Number: NCT01349816

PT003 MDI Dose Confirmation Study

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pearl Investigative Site, Rancho Mirage, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PT003

Drug

PT003 MDI administered as two puffs BID for 7 days

PT001

Drug

PT001 MDI administered as two puffs BID for 7 days

PT005

Drug

PT005 MDI administered as two puffs BID for 7 days

Primary outcomes

  1. FEV1 AUC0-12

    Time frame: Day 7

    Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).

Secondary outcomes

  1. Peak Change From Baseline in FEV1

    Time frame: Day 1

    Peak change from baseline in FEV1 through 2 hours

  2. Time to Onset of Action

    Time frame: Day 1

    At least 10% improvement in mean FEV1

  3. At Least 12% Improvement in FEV1

    Time frame: Day 1

    Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline

  4. Peak Change in IC

    Time frame: Day 1

    Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline

  5. Morning Pre-dose FEV1

    Time frame: Day 7

    Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)

  6. FEV1 Through 6 Hours

    Time frame: Day 7

    Peak change from baseline in FEV1 through 6 hours

  7. Peak Change From Baseline in IC

    Time frame: Day 7

    Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)

  8. Mean Evening Trough FEV1

    Time frame: Day 7

    Change from baseline in mean evening 12-hour post-dose trough FEV1

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 9, 2011
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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