Effect of Brovana and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 4 · Has a placebo group

Conditions studied: COPD

In brief

This will be a double-blind crossover trial in 20 patient with stable COPD. Data from this study will provide proof-of-concept information on whether the (anticipated) additional bronchodilator effect of Brovana added to tiotropium will lead to a meaningful improvement in the patient-centered outcome, exercise capacity. This study will only evaluate the effects of short-term (1-week) administration of Brovana. If results are positive, it would provide preliminary data for further, multicenter investigations.

Key facts

Study ID

NCT00773786

Run by

Trinity Health Of New England

People needed

20

Starts

2008-10-01

Expected to finish

2009-05-01

Last updated by the study team

2019-08-06

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent (Approval by the St. Francis Hospital Institutional Review Board (IRB) will be required before study initiation)
• Adults, age > 40 years
• A clinical diagnosis of COPD, with spirometric confirmation: post-bronchodilator forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC) ( < 0.70
• Moderate, severe and very severe airflow limitation by GOLD criteria.
• Clinically stable respiratory disease
• The perceived ability to participate in pulmonary testing and exercise testing
• COPD, stable state

You may not qualify if…

• Women of childbearing potential
• Asthma
• Supplemental oxygen use or anticipated oxygen desaturation < 85% at peak exercise (patients who desaturate below 85% on the incremental study will be excluded)
• Co-morbidity that would interfere with the patient participating in the study, including the exercise testing. Examples include unstable cardiac disease, arthritis, psychological problems that would interfere with participation
• An exacerbation requiring therapy or any change in maintenance COPD therapy within six weeks of testing
• A history of a prolonged QT interval
• Recent exacerbation of COPD

Where it is running

• St Francis Hospital and Medical center — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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