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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PT001 18 mcg

Inhaled PT001 18 mcg

Group Type EXPERIMENTAL

Inhaled PT001

Intervention Type DRUG

single dose, inhaled

PT001 36 mcg

Inhaled PT001 36 mcg

Group Type EXPERIMENTAL

Inhaled PT001

Intervention Type DRUG

single dose, inhaled

PT001 72 mcg

Inhaled PT001 72 mcg

Group Type EXPERIMENTAL

Inhaled PT001

Intervention Type DRUG

single dose, inhaled

PT001 144 mcg

Inhaled PT001 144 mcg

Group Type EXPERIMENTAL

Inhaled PT001

Intervention Type DRUG

single dose, inhaled

Inhaled Placebo

Group Type PLACEBO_COMPARATOR

Inhaled Placebo

Intervention Type DRUG

single dose, inhaled

Tiotropium Handihaler

Tiotropium 18 mcg administered via Handihaler

Group Type ACTIVE_COMPARATOR

Tiotropium Handihaler

Intervention Type DRUG

single dose, tiotropium 18 mcg administered via the Handihaler

Interventions

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Inhaled PT001

single dose, inhaled

Intervention Type DRUG

Inhaled Placebo

single dose, inhaled

Intervention Type DRUG

Tiotropium Handihaler

single dose, tiotropium 18 mcg administered via the Handihaler

Intervention Type DRUG

Other Intervention Names

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Spiriva

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No