Overview

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

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Collaborator:
Forest Laboratories
Treatments:
Albuterol
Criteria
Inclusion Criteria:

- 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.-

Exclusion Criteria:

- 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