Overview

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

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pearl Therapeutics, Inc.
Treatments:
Bromides
Ipratropium
Criteria
Key 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

Key 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

Other inclusion/exclusion criteria as defined in the protocol