None listed
Conditions
Brief summary
Thirty-two subjects diagnosed with COPD will be enrolled with the goal of at least 28 subjects receiving each study treatment and completing the follow-up assessments. During each of the four study periods, subjects will be admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests will be performed and PK samples collected up to 25 hours. Subjects will be discharged from the clinic on Day 2 after evaluations.
Interventions
Single doses of 2 dose levels (350 and 700 micrograms) of TD 4208 by inhalation via a nebulizer: 7-12 days apart.
Comparators are single doses of ipratropium bromide (500 micrograms) and placebo.
Subjects crossover to single doses of all four treatments.
The washout is a minium of 7 days and a maximum of 12 days between each single dose.
The 7-12 day period is determined by the clinic's schedule, the availability of the subjects and the re-assessment of eligibility criteria prior to each of t
Single doses of 2 dose levels (350 and 700 micrograms) of TD 4208 by inhalation via a nebulizer: 7-12 days apart. Comparators are single doses of ipratropium bromide (500 micrograms) and placebo. Subjects crossover to single doses of all four treatments. The washout is a minium of 7 days and a maximum of 12 days between each single dose. The 7-12 day period is determined by the clinic's schedule, the availability of the subjects and the re-assessment of eligibility criteria prior to each of the subsequent single doses.
Sponsors
Theravance, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
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 hypertorphy, 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, cardiovacular disease or abnormal ECG. History of drug or alcohol abuse.
Outcome results
None listed