PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01566773

Run by

Pearl Therapeutics, Inc.

People needed

140

Starts

2012-03-01

Expected to finish

2012-08-01

Last updated by the study team

2017-10-12

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pearl Investigative Site — Fullerton, California, United States
• Pearl Investigative Site — Clearwater, Florida, United States
• Pearl Investigative Site — Panama City, Florida, United States
• Pearl Investigative Site — Tampa, Florida, United States
• Pearl Investigative Site — Winter Park, Florida, United States
• Pearl Investigative Site — Charlotte, North Carolina, United States
• Pearl Investigative Site — Medford, Oregon, United States
• Pearl Investigative Site — Spartanburg, South Carolina, United States
• Pearl Investigative Site — Longview, Texas, United States
• Pearl Investigative Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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