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OpenTrials
Completed

NCT Number: NCT01085045

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austrials, Caringbah, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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 protocol defined inclusion/exclusion criteria may apply

Treatment and study plan

PT003 MDI

Drug

Inhaled PT003 MDI administered as two puffs BID for 7 days

PT005 MDI

Drug

Inhaled PT005 MDI administered as two puffs BID for 7 days

Placebo MDI

Drug

Inhaled placebo administered as two puffs BID for 7 days

Tiotropium bromide 18 μg (Spiriva Handihaler®)

Drug

Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Drug

Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days

PT001 MDI

Drug

Inhaled PT001 MDI administered as two puffs BID for 7 days

Primary outcomes

  1. FEV1 AUC 0-12 on Day 7

    Time frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7

    Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration

Secondary outcomes

  1. Peak Change From BL in FEV1 on Day 1

    Time frame: Day 1

    Peak change from Baseline in FEV1 on Day 1

  2. Peak Change From BL in FEV1 on Day 7

    Time frame: Day 7

    Peak change from Baseline (BL) in FEV1 on Day 7

  3. Peak Change From BL in Inspiratory Capacity on Day 1

    Time frame: Day 1

    Peak change from Baseline in Inspiratory Capacity (IC) on Day 1

  4. Peak Change From BL IC on Day 7

    Time frame: Day 7

    Peak Change from Baseline Inspiratory Capacity on following 7-day dose administration

  5. Time to Onset of Action >=10% Improvement in FEV1 on Day 1

    Time frame: Day 1

    Time to Onset of Action where the improvement in FEV1 on Day 1 was >=10%

  6. Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1

    Time frame: Day 1

    Time to Onset of Action where the improvement in FEV1 on Day 1 was >= 12%

  7. Change in Morning Pre-dose FEV1 on Day 7

    Time frame: Day 7

    Change from Baseline in morning pre-dose FEV1 on Day 7

  8. 12 hr Post-dose Trough FEV1 on Day 7

    Time frame: Day 7

    12 hour post-dose trough Forced Expiratory Volume in 1 second on Day 7

  9. Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7

    Time frame: Day 7

    Change from BaseLine in mean morning pre-dose daily peak flow rate on Day 7

  10. Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7

    Time frame: Day 7

    Change from BaseLine in mean morning post-dose daily peak flow rate on Day 7

  11. Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7

    Time frame: Day 7

    Change from BaseLine in mean evening pre-dose daily peak flow rate on Day 7

  12. Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7

    Time frame: Day 7

    Change from BaseLine in mean evening post-dose daily peak flow rate on Day 7

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 11, 2010
Registry last updated
Apr 26, 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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