Trial Outcomes & Findings for Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis (NCT NCT00359736)
NCT ID: NCT00359736
Last Updated: 2017-11-01
Results Overview
Distance in meters -- Distance (meters) walked in 6 minutes
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
0 - 6 months
Results posted on
2017-11-01
Participant Flow
2006-2009; U Miami and VA IPF clinics
Some were excluded after enrollment, because they did not meet entry criteria.
Participant milestones
| Measure |
Sildenafil
Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
|
Placebo
Control group: Identical Placebo 20 mg TID orally
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
Sildenafil
n=14 Participants
Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
|
Placebo
n=15 Participants
Identical Placebo: 20 mg TID orally
|
Total
n=29 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
71.0 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
70.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 - 6 monthsDistance in meters -- Distance (meters) walked in 6 minutes
Outcome measures
| Measure |
Sildenafil
n=14 Participants
Sildenafil 20 mg tid
sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
|
Placebo
n=15 Participants
Identical Placebo 20 mg tid
|
|---|---|---|
|
Change in 6-minute Walk Test
|
-26 meters
Standard Deviation 45
|
-7 meters
Standard Deviation 34
|
SECONDARY outcome
Timeframe: 0 - 6 monthsThe Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test. The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness). IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups.
Outcome measures
| Measure |
Sildenafil
n=14 Participants
Sildenafil 20 mg tid
sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
|
Placebo
n=15 Participants
Identical Placebo 20 mg tid
|
|---|---|---|
|
Dyspnea Score (Borg Scale)
Pre-Exercise Dypsnea score
|
0.86 units on a scale
Standard Deviation 1.77
|
0.38 units on a scale
Standard Deviation 1.39
|
|
Dyspnea Score (Borg Scale)
Post-Exercise Dypsnea score
|
0.89 units on a scale
Standard Deviation 2.11
|
0.15 units on a scale
Standard Deviation 1.68
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sildenafil
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Control group
|
Sildenafil
n=14 participants at risk
sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
|
|---|---|---|
|
General disorders
Flushing
|
6.7%
1/15 • Number of events 1 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/15 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
|
Cardiac disorders
Chest pain
|
0.00%
0/15 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
|
Eye disorders
Change in vision
|
0.00%
0/15 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
|
General disorders
Syncope
|
0.00%
0/15 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • 3 years
No additional follow up
|
7.1%
1/14 • Number of events 1 • 3 years
No additional follow up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place