Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

June 12, 2013 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium

The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Miami, Florida, United States, 33169
        • Elite Research Institute
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Pulmonary and Critical Care Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VAMC
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • 40 - 75 years of age
  • Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
  • COPD diagnosis
  • Current/former smokers with at least a 10 pack-year history of cigarette smoking
  • Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
  • Must demonstrate reversibility to ipratropium demonstrated by a >200 mL improvement over baseline and/or >12% and >150 mL improvement over baseline
  • Patients willing to stay at study site for at least 24 hours on each test day

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 24 weeks of Screening
  • Unable to perform acceptable spirometry
  • Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
  • Clinically significant medical conditions
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • Lower respiratory tract infection requiring antibiotics in past 6 weeks
  • Clinically significant abnormal ECG
  • Clinically significant uncontrolled hypertension
  • Positive Hepatitis B surface antigen or Hepatitis C antibody
  • Cancer that has not been in complete remission for at least 5 years
  • History of hypersensitivity to any beta2-agonists or anticholinergics
  • History of severe milk protein allergy
  • Known or suspected history of alcohol or drug abuse
  • Medically unable to withhold short acting bronchodilators for 6-hours
  • Use of the medications below in specified time interval prior to Screening: 3 months: depot corticosteroids, intra-articular corticosteroids; 6 weeks: oral corticosteroids, antibiotics administered for a COPD exacerbation; and 1 month: P-glycoprotein inhibitors, CYP450 3A4 inhibitors, ICS >1000 μg/day of fluticasone propionate or equivalent
  • The following COPD medications need to be stopped and switched to appropriate replacement therapies: tiotropium, oral beta2 agonists, LABAs, combination corticosteroid/LABAs, theophylline, leukotriene inhibitors,cromoglycate and nedocromil
  • Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates, hydantoins, and carbamazepine and phenothiazines
  • Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
  • Diagnosis of sleep apnea that is uncontrolled
  • Participation in acute phase of pulmonary rehabilitation in prior 4 weeks
  • Will enter acute phase of pulmonary rehabilitation program during study
  • Unable to comply with study procedures
  • Affiliated with Investigator site
  • Questionable validity of consent
  • Use of investigational study drug/participation in clinical study in the last 30 days or 5 half lives prior to Screening, whichever is longer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PT001 18 mcg
Inhaled PT001 18 mcg
Drug: Inhaled PT001
single dose, inhaled
Experimental: PT001 36 mcg
Inhaled PT001 36 mcg
Drug: Inhaled PT001
single dose, inhaled
Experimental: PT001 72 mcg
Inhaled PT001 72 mcg
Drug: Inhaled PT001
single dose, inhaled
Experimental: PT001 144 mcg
Inhaled PT001 144 mcg
Drug: Inhaled PT001
single dose, inhaled
Placebo Comparator: Inhaled Placebo
Drug: Inhaled Placebo
single dose, inhaled
Active Comparator: Tiotropium Handihaler
Tiotropium 18 mcg administered via Handihaler
Drug: Tiotropium Handihaler
single dose, tiotropium 18 mcg administered via the Handihaler
Other Names:
  • Spiriva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak improvement in forced expiratory volume in one second (FEV1)
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to onset of action (>10% improvement in FEV1 from baseline)
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1
Time to peak FEV1
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1
FEV1 area under the curve (AUC) from 0 to 24 hours
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1
FEV1 AUC from 0 to 12 hours
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1
Trough FEV1 at 12 and 24 hours
Time Frame: Day 1
Day 1 serial FEV1 measured over 24 hours
Day 1
Peak Improvement in inspiratory capacity (IC)
Time Frame: Day 1
Day 1 serial IC measured over 24 hours
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pearl Therapeutics, Inc.

Investigators

  • Study Director: Colin Reisner, M.D., Pearl Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 27, 2009

First Posted (Estimate)

March 30, 2009

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT0010801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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