Study to Evaluate the Safety and Efficacy of inhaled PT001 in patients with chronic obstructive pulmonary disease (COPD)

Study identifier:PT0010801

ClinicalTrials.gov identifier:NCT00871182

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Healthy volunteers

Study drug

Inhaled PT001, Inhaled Placebo, Tiotropium Handihaler

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 75 Years

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: 01 Sept 2009

Study Completion Date: 01 Sept 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion 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

No locations available

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

Contacts

Contact

Lawrence Reiter

416-977-0095

[email protected]

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics, Inc.