Trial Outcomes & Findings for Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis (NCT NCT00981747)
NCT ID: NCT00981747
Last Updated: 2018-11-13
Results Overview
Change in 6MWD before and after treatment compared to placebo
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
12 participants
Primary outcome timeframe
At baseline and three months post each intervention.
Results posted on
2018-11-13
Participant Flow
Participant milestones
| Measure |
All Study Participants
Participants will be randomized to take one of the study medications (Sildenafil, Losartan, placebo oral tablet, and Sildenafil and Losartan) at a time. Participants will be randomized to take these medications for 3 months with a washout period of one month before starting the next medication. The order or medications taken is random in order to blind the investigator and participant
|
|---|---|
|
Losartan
STARTED
|
12
|
|
Losartan
Started Losartan
|
12
|
|
Losartan
Completed Losartan
|
10
|
|
Losartan
COMPLETED
|
10
|
|
Losartan
NOT COMPLETED
|
2
|
|
Placebo Oral Tablet
STARTED
|
10
|
|
Placebo Oral Tablet
Started Placebo Oral Tablet
|
10
|
|
Placebo Oral Tablet
Completed Placebo Oral Tablet
|
9
|
|
Placebo Oral Tablet
COMPLETED
|
9
|
|
Placebo Oral Tablet
NOT COMPLETED
|
1
|
|
Sildenafil
STARTED
|
9
|
|
Sildenafil
Started Sildenafil
|
9
|
|
Sildenafil
Completed Sildenafil
|
9
|
|
Sildenafil
COMPLETED
|
9
|
|
Sildenafil
NOT COMPLETED
|
0
|
|
Sildenafil and Losartan
STARTED
|
9
|
|
Sildenafil and Losartan
Started Sildenafil and Losartan
|
9
|
|
Sildenafil and Losartan
Completed Sildenafil and Losartan
|
9
|
|
Sildenafil and Losartan
COMPLETED
|
9
|
|
Sildenafil and Losartan
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Study Participants
Participants will be randomized to take one of the study medications (Sildenafil, Losartan, placebo oral tablet, and Sildenafil and Losartan) at a time. Participants will be randomized to take these medications for 3 months with a washout period of one month before starting the next medication. The order or medications taken is random in order to blind the investigator and participant
|
|---|---|
|
Losartan
Withdrawal by Subject
|
1
|
|
Losartan
Death
|
1
|
|
Placebo Oral Tablet
Withdrawal by Subject
|
1
|
Baseline Characteristics
Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
Study participants are patients that have been diagnosed with idiopathic pulmonary fibrosis (IPF).
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and three months post each intervention.Change in 6MWD before and after treatment compared to placebo
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Sildenafil: Sildenafil 20mg three times per day for 3 months
|
Losartan
n=9 Participants
Losartan: Losartan 25mg two times a day for 3 months
|
Sildenafil and Losartan
n=9 Participants
Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
|
Placebo
n=9 Participants
Placebo pill: Placebo pill three times per day for 3 months
|
|---|---|---|---|---|
|
Change in Six Minute Walk Distance in Meters
|
10.5 meters
Standard Deviation 23.1
|
15.8 meters
Standard Deviation 24.0
|
-11.1 meters
Standard Deviation 12.0
|
12.1 meters
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: At baseline and three months post each intervention.Change in FVC before and after treatment compared to placebo. FVC is a measure of lung size.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Sildenafil: Sildenafil 20mg three times per day for 3 months
|
Losartan
n=9 Participants
Losartan: Losartan 25mg two times a day for 3 months
|
Sildenafil and Losartan
n=9 Participants
Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
|
Placebo
n=9 Participants
Placebo pill: Placebo pill three times per day for 3 months
|
|---|---|---|---|---|
|
Change in Forced Vital Capacity (FVC)
|
-0.04 liters
Standard Deviation .13
|
-0.06 liters
Standard Deviation 0.13
|
0.002 liters
Standard Deviation 0.14
|
-0.02 liters
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: At baseline and three months post each intervention.Change in symptoms of SOB as determined by St. Georges Respiratory Questionnaire score. This score ranges from 0 to 100 with a higher score indicating more problems breathing.
Outcome measures
| Measure |
Sildenafil
n=9 Participants
Sildenafil: Sildenafil 20mg three times per day for 3 months
|
Losartan
n=9 Participants
Losartan: Losartan 25mg two times a day for 3 months
|
Sildenafil and Losartan
n=9 Participants
Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
|
Placebo
n=9 Participants
Placebo pill: Placebo pill three times per day for 3 months
|
|---|---|---|---|---|
|
Change in Shortness of Breath (SOB) Score
|
2.1 score on a scale
Standard Deviation 10.3
|
1.5 score on a scale
Standard Deviation 5.7
|
3.3 score on a scale
Standard Deviation 11.6
|
-3.0 score on a scale
Standard Deviation 9.8
|
Adverse Events
Sildenafil
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Losartan
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Sildenafil and Losartan
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sildenafil
n=9 participants at risk
Sildenafil: Sildenafil 20mg three times per day for 3 months
|
Losartan
n=12 participants at risk
Losartan: Losartan 25mg two times a day for 3 months
|
Sildenafil and Losartan
n=9 participants at risk
Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
|
Placebo
n=10 participants at risk
Placebo pill: Placebo pill three times per day for 3 months
|
|---|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis Exacerbation
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
Other adverse events
| Measure |
Sildenafil
n=9 participants at risk
Sildenafil: Sildenafil 20mg three times per day for 3 months
|
Losartan
n=12 participants at risk
Losartan: Losartan 25mg two times a day for 3 months
|
Sildenafil and Losartan
n=9 participants at risk
Sildenafil and Losartan: Sildenafil 20mg three times per day and Losartan 25mg two times per day.
|
Placebo
n=10 participants at risk
Placebo pill: Placebo pill three times per day for 3 months
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1
|
41.7%
5/12 • Number of events 5
|
33.3%
3/9 • Number of events 3
|
20.0%
2/10 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Flushing
|
33.3%
3/9 • Number of events 3
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory infection/viral illness
|
22.2%
2/9 • Number of events 2
|
8.3%
1/12 • Number of events 1
|
55.6%
5/9 • Number of events 5
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 3
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
11.1%
1/9 • Number of events 1
|
0.00%
0/12
|
22.2%
2/9 • Number of events 2
|
0.00%
0/10
|
|
Cardiac disorders
Edema
|
11.1%
1/9 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Fatigue
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/9
|
0.00%
0/12
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Sinusitis
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/9
|
8.3%
1/12 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place