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

Conditions

• COPD

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast Placebo — DRUG
  Placebo pill
• Roflumilast — DRUG
  500 Ug ORAL TABLET

Study Details

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 Dates

Start date

Feb 28, 2013

Status verified

Oct 2017

Primary completion

Jul 31, 2015

Completion

Jul 31, 2015

Study Design

Enrollment

11 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: SD placebo and MD roflumilast then MD placebo
  Participants will receive placebo (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily.
• Experimental: SD placebo and MD placebo then MD roflumilast
  Participants will receive placebo (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
• Experimental: SD roflumilast and MD placebo then MD roflumilast.
  Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with placebo daily, followed by a 4 week washout period, followed by a 4 week treatment with 500ug roflumilast daily.
• Experimental: SD roflumilast and MD roflumilast then MD placebo
  Participants will receive 500ug roflumilast (single dose) followed by a 4 week treatment with 500ug roflumilast daily, followed by a 4 week washout period, followed by a 4 week treatment with placebo daily

Primary Outcome Measure

Airway Blood Flow Reactivity (Delta Qaw) [ Time Frame: Immediate or 4 weeks ]

Locations (1)

Find similar trials in Miami, FL

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