Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COPD

In brief

The objectives of the proposed study are to determine 1) the effect of a single dose of Roflumilast on airway blood flow (Qaw) (study period 1) and 2) the effect of long-term Roflumilast treatment on airway blood flow reactivity delta Qaw)(study period 2) in patients with stable COPD who use ICS regularly.

Key facts

Study ID

NCT02097992

Run by

University of Miami

People needed

11

Starts

2013-02-01

Expected to finish

2015-07-01

Last updated by the study team

2017-11-24

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Twenty-four patients with physician-diagnosed COPD (female and male, current smokers or ex-smokers) over the age of 45 years will be recruited for this study.
• The patients will have to have a smoking history of at least 10 pack-years, and they must have been using an ICS regularly for at least 4 weeks at the time of screening.
• Confirmation of the diagnosis of COPD will require the presence of persistent exertional dyspnea and a post-bronchodilator FEV1 of less than 80% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2). At entry into the study, the patients will have to be clinically stable; they will be allowed to remain on their regular COPD treatment regimen and use a LABA and/or LAMA until 24 hours before, and a SABA and/or short-acting muscarinic antagonist (SAMA) until 6 hours before coming to the laboratory. If using roflumilast, the subjects will have to discontinue it 4 weeks before entering into the study.-

You may not qualify if…

• Women of childbearing potential who do not use accepted birth control measures
• Pregnant and breast-feeding women.
• Use of cardiovascular medications that cannot be held on the study days
• Use of oral airway medications or anti-inflammatory agents
• Use of supplemental oxygen that cannot be discontinued during the laboratory visit
• Subjects with known SABA or roflumilast intolerance
• An acute COPD exacerbation within four weeks prior to the study

Where it is running

• University of Miami Divison of Pulmonary and Critical Care Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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