PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-01

Study Completion Date

2011-10-01

Brief Summary

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The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

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Detailed Description

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The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

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 MDI (Dose 1)

PT001 MDI

Group Type EXPERIMENTAL

PT001 MDI

Intervention Type DRUG

PT001 MDI administered as two puffs BID for 7 days

PT001 MDI (Dose 2)

PT001 MDI

Group Type EXPERIMENTAL

PT001 MDI

Intervention Type DRUG

PT001 MDI administered as two puffs BID for 7 days

PT001 MDI (Dose 3)

PT001 MDI

Group Type EXPERIMENTAL

PT001 MDI

Intervention Type DRUG

PT001 MDI administered as two puffs BID for 7 days

PT001 MDI (Dose 4)

PT001 MDI

Group Type EXPERIMENTAL

PT001 MDI

Intervention Type DRUG

PT001 MDI administered as two puffs BID for 7 days

Ipratropium Bromide HFA Inhalation Aerosol

Group Type ACTIVE_COMPARATOR

Ipratropium Bromide HFA Inhalation Aerosol

Intervention Type DRUG

Taken as 2 inhalations of the 17 µg per actuation strength MDI QID

Placebo MDI

PT001 Placebo MDI

Group Type PLACEBO_COMPARATOR

Placebo MDI

Intervention Type OTHER

Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Interventions

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PT001 MDI

PT001 MDI administered as two puffs BID for 7 days

Intervention Type DRUG

Ipratropium Bromide HFA Inhalation Aerosol

Taken as 2 inhalations of the 17 µg per actuation strength MDI QID

Intervention Type DRUG

Placebo MDI

Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Intervention Type OTHER

Other Intervention Names

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Atrovent

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No