Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.; Theravance Biopharma R & D, Inc.
• Collaborator: Theravance Biopharma
• Treatments: Ipratropium

Criteria

Inclusion Criteria:

• Diagnosis of moderate stable Chronic Obstructive Pulmonary.

• Disease with FEV1/FVC <0.7 at screening.

• Woman of non-childbearing potential.

• Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth control during the study and for at least 1 month after completion of study dosing.

• Female participants must not be breastfeeding.

• Men must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.

• Current or past smoking history >10 pack-years.

• Must be capable of performing reproducible spirometry maneuvers.

Exclusion Criteria:

• History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.

• Exacerbation of COPD, lung infection within 6 weeks prior to study.

• Start of or change in dose of COPD treatment 4 weeks before study.

• Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).

• Use of bronchodilators or medication for the treatment of COPD, aspirin, anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.

• Symptomatic prostrate hypertrophy, bladder neck obstruction, active cancer, narrow angle glaucoma.

• Clinical significant hypersensitivity to medications.

• Participants have an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine or other disease that may place participant at risk.

• Cerebrovascular, cardiovascular disease or abnormal ECG.

• History of drug or alcohol abuse.