Trial Outcomes & Findings for Sildenafil for Chronic Obstructive Pulmonary Disease (NCT NCT00104637)
NCT ID: NCT00104637
Last Updated: 2012-05-21
Results Overview
The distance a subject walked within 6 minutes was measured and documented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Period 1 and Period 3 ( within 8 weeks)
Results posted on
2012-05-21
Participant Flow
The recruitment period began in February 2005 and ended by November 2008.
Participant milestones
| Measure |
Sildenafil /Placebo
25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
|
Placebo /Sildenafil
25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
|
|---|---|---|
|
Period 1: ( TREATMENT: 4 Weeks)
STARTED
|
6
|
4
|
|
Period 1: ( TREATMENT: 4 Weeks)
COMPLETED
|
5
|
4
|
|
Period 1: ( TREATMENT: 4 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (WASHOUT: 1 Week)
STARTED
|
5
|
4
|
|
Period 2 (WASHOUT: 1 Week)
COMPLETED
|
5
|
4
|
|
Period 2 (WASHOUT: 1 Week)
NOT COMPLETED
|
0
|
0
|
|
Period 3 ( TREATMENT: 4 Weeks)
STARTED
|
5
|
4
|
|
Period 3 ( TREATMENT: 4 Weeks)
COMPLETED
|
5
|
4
|
|
Period 3 ( TREATMENT: 4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sildenafil /Placebo
25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
|
Placebo /Sildenafil
25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
|
|---|---|---|
|
Period 1: ( TREATMENT: 4 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Sildenafil for Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Randomized Participants
n=10 Participants
All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)The distance a subject walked within 6 minutes was measured and documented.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
6 Minute Walk Distance
|
458.2 meters
Interval 380.0 to 536.0
|
466.1 meters
Interval 388.0 to 544.0
|
PRIMARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
VO2 Peak (Oxygen Consumption at Peak Exercise)
|
13.7 ml/kg/min
Interval 10.3 to 17.0
|
13.8 ml/kg/min
Interval 10.3 to 17.3
|
SECONDARY outcome
Timeframe: Period 1 (4 weeks)Data to calculate results for FVC was based on Period 1.
Outcome measures
| Measure |
Sildenafil
n=6 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=4 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Pulmonary Function FVC (Forced Vital Capacity)
|
2.8 liters
Interval 2.2 to 3.3
|
2.8 liters
Interval 2.2 to 3.3
|
SECONDARY outcome
Timeframe: Period 1 ( 4 weeks)The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.
Outcome measures
| Measure |
Sildenafil
n=6 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=4 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Forced Expiratory Volume in the First Second (FEV1 )
|
1.1 liters
Interval 0.6 to 1.5
|
1.1 liters
Interval 0.7 to 1.6
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
|
3.9 Scores on a scale
Interval 2.0 to 5.9
|
3.8 Scores on a scale
Interval 1.8 to 5.9
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Diffusing Capacity of Carbon Monoxide (DLCO)
|
11 ml/min/torr
Interval 7.1 to 15.0
|
11 ml/min/torr
Interval 7.1 to 15.0
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
|
42 mm Hg
Interval 38.0 to 45.0
|
40 mm Hg
Interval 36.0 to 43.0
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Partial Pressure of Oxygen in ABG breathing room air at rest.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
|
73 mm Hg
Interval 66.0 to 79.0
|
77 mm Hg
Interval 71.0 to 84.0
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)A-a gradient was measured with ABG breathing room air at rest.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
A-a Gradient (Alveolar-arterial Gradient)
|
25 mm Hg
Interval 19.0 to 33.0
|
23 mm Hg
Interval 16.0 to 57.0
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
Oxygen Pulse
|
8.7 ml/beat
Interval 6.4 to 11.0
|
9.5 ml/beat
Interval 7.1 to 11.9
|
SECONDARY outcome
Timeframe: Period 1 and Period 3 ( within 8 weeks)O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.
Outcome measures
| Measure |
Sildenafil
n=10 Participants
Sildenafil citrate 25 mg by mouth three times a day
|
Placebo
n=9 Participants
Placebo by mouth three times a day.
|
|---|---|---|
|
O2 Saturation at Peak Exercise
|
95 percentage of oxygen saturation
Interval 92.0 to 98.0
|
96 percentage of oxygen saturation
Interval 93.0 to 99.0
|
Adverse Events
Sildenafil
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sildenafil
n=10 participants at risk
25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
|
Placebo
n=9 participants at risk
25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
11.1%
1/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
Eye disorders
Blurry vision
|
30.0%
3/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Headache
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Pleuritic pain
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Nasal Congestion
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respirartory tract infection
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Epistaxis
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
Musculoskeletal and connective tissue disorders
Rib Pain
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Facial Flushing
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
0.00%
0/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
|
General disorders
Dizziness
|
10.0%
1/10 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
11.1%
1/9 • 9 weeks
Adverse events were monitored during the clinical trial period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60