Trial Outcomes & Findings for Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD (NCT NCT02097992)
NCT ID: NCT02097992
Last Updated: 2017-11-24
Results Overview
percentage of change on airway blood flow induced by albuterol.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Immediate or 4 weeks
Results posted on
2017-11-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|
|
Treatment 1 (1 Day)
STARTED
|
2
|
3
|
4
|
2
|
|
Treatment 1 (1 Day)
COMPLETED
|
2
|
3
|
4
|
2
|
|
Treatment 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment 2 (4 Weeks)
STARTED
|
2
|
3
|
4
|
2
|
|
Treatment 2 (4 Weeks)
COMPLETED
|
2
|
3
|
4
|
2
|
|
Treatment 2 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (4 Weeks)
STARTED
|
2
|
3
|
4
|
2
|
|
Washout (4 Weeks)
COMPLETED
|
2
|
3
|
4
|
2
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment 3 (4 Weeks)
STARTED
|
2
|
3
|
4
|
2
|
|
Treatment 3 (4 Weeks)
COMPLETED
|
2
|
3
|
4
|
2
|
|
Treatment 3 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Roflumilast on Airway Blood Flow as an Expression of Airway Inflammation in COPD
Baseline characteristics by cohort
| Measure |
SD Placebo and MD Roflumilast Then MD Placebo
n=2 Participants
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.
|
SD Placebo and MD Placebo Then MD Roflumilast
n=3 Participants
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.
|
SD Roflumilast and MD Placebo Then MD Roflumilast.
n=4 Participants
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.
|
SD Roflumilast and MD Roflumilast Then MD Placebo
n=2 Participants
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
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Immediate or 4 weekspercentage of change on airway blood flow induced by albuterol.
Outcome measures
| Measure |
Long Term Multidose Roflumilast or Placebo
n=11 Participants
Treatment with 500ug roflumilast or placebo for 4 weeks
|
Acute Roflumilast or Placebo
n=11 Participants
Treatment with a single dose of 500ug roflumilast or placebo
|
|---|---|---|
|
Airway Blood Flow Reactivity (Delta Qaw)
roflumilast
|
29.1 % of change
Standard Error 6.8
|
13.7 % of change
Standard Error 9.5
|
|
Airway Blood Flow Reactivity (Delta Qaw)
placebo
|
8.9 % of change
Standard Error 4.6
|
15.6 % of change
Standard Error 10.3
|
Adverse Events
Single Dose Roflumilast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single Dose Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multi-dose Roflumiast
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Multi-dose Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Dose Roflumilast
n=6 participants at risk
Participants received a single dose of 500Ug of Roflumilast for one day.
|
Single Dose Placebo
n=5 participants at risk
Participants received a single dose Placebo for one day.
|
Multi-dose Roflumiast
n=11 participants at risk
Participants received a daily dose of 500Ug of Roflumilast for four weeks.
|
Multi-dose Placebo
n=11 participants at risk
Participants received a daily Placebo dose for four weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
increase of cough
|
0.00%
0/6
|
0.00%
0/5
|
9.1%
1/11 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place