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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00871182
First received: March 26, 2009
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Inhaled PT001
Drug: Inhaled Placebo
Drug: Tiotropium Handihaler
Phase 1
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, 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

Resource links provided by NLM:


Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:
  • Peak improvement in forced expiratory volume in one second (FEV1) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours


Secondary Outcome Measures:
  • Time to onset of action (>10% improvement in FEV1 from baseline) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours

  • Time to peak FEV1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours

  • FEV1 area under the curve (AUC) from 0 to 24 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours

  • FEV1 AUC from 0 to 12 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours

  • Trough FEV1 at 12 and 24 hours [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial FEV1 measured over 24 hours

  • Peak Improvement in inspiratory capacity (IC) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Day 1 serial IC measured over 24 hours


Enrollment: 33
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: Spiriva

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00871182

Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
Elite Research Institute
Miami, Florida, United States, 33169
United States, Nebraska
Pulmonary and Critical Care Medicine
Omaha, Nebraska, United States, 68198
United States, Ohio
Cincinnati VAMC
Cincinnati, Ohio, United States, 45220
United States, South Carolina
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, M.D. Pearl Therapeutics, Inc.
  More Information

No publications provided by Pearl Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00871182     History of Changes
Other Study ID Numbers: PT0010801
Study First Received: March 26, 2009
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pearl Therapeutics, Inc.:
COPD
obstructive lung diseases
Tiotropium

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

ClinicalTrials.gov processed this record on October 23, 2014