A Phase 3 interventional study of Sildenafil Citrate and Placebo in Pulmonary Fibrosis and Hypertension, Pulmonary, sponsored by Duke University. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-24.
Sponsored by Duke University · Phase 3, Interventional, and Treatment
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.
IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks blood from flowing through the lungs effectively, reducing the amount of oxygen in the lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available. These factors can cause breathing difficulties and may eventually lead to heart disease. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.
This study will enroll people with advanced IPF. Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years following the end of the study to determine the incidence of death among study participants.
685 studies on the registry are indexed under Pulmonary Fibrosis; 120 are open to participants now.
This study's enrollment of 180 is above the median of 50 across 421 interventional studies indexed under Pulmonary Fibrosis.
Browse Pulmonary Fibrosis studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Exclusion Criteria:
20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks
Drug: Sildenafil Citrate
20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks
Other: Placebo
Sildenafil citrate (20mg 3 times a day \[TID\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)
Also known as: Revatio
Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)
Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)
This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Measured at Week 12
6-minute Walk Distance (6MWT)
The 6MWT measures the distance that a participant can walk in a period of 6 minutes.
Time frame: Baseline, 6 week, 12 week
Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance
The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, week 12
Desaturation During 6-minute Walk Test (6MWT)
The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.
Time frame: Week 12
Change in Dyspnea
The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.
Time frame: Measured from enrollment to 12 weeks (phase I)
University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total
The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Forced Vital Capacity (FVC) Adjusted Values
Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, Week 12
Forced Vital Capacity (FVC)
Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups
Time frame: Baseline, Week 6, Week 12
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values
Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, Week 12
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups
Time frame: Baseline, Week 6, Week 12
Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values)
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 week
Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores)
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.
Time frame: Baseline, 6 week, 12 week
Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values)
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 week
St. George's Respiratory Questionnaire (Total Score)
Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)
Time frame: Baseline, 6 weeks, 12 weeks
Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
St. George's Respiratory Questionnaire (Symptoms Score)
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire.
Time frame: Baseline, 6 weeks, 12 weeks
Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
St. George's Respiratory Questionnaire (Activity Score)
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.
Time frame: Baseline, 6 weeks, 12 weeks
Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
St. George's Respiratory Questionnaire (Impacts Score)
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.
Time frame: Baseline, 6 weeks, 12 weeks
Change in ICECAP-O Adjusted Value
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
ICECAP-O
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.
Time frame: Baseline, 6 weeks, 12 weeks
Change in EuroQOL Thermometer (Adjusted Value)
The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
EuroQOL Thermometer
The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state. Mean raw scores of EuroQOL Thermometer.
Time frame: Baseline, 6 weeks, 12 weeks
Change in EuroQOL (EQ-5D) Utility - Adjusted Value
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
EuroQOL (EQ-5D) Utility
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. Mean raw scores of EuroQOL Utility.
Time frame: Baseline, 6 weeks, 12 weeks
Change in Short Form Health Survey (SF36) General Health - Adjusted Value
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
Short Form Health Survey (SF36) General Health
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Mean raw scores of SF36 General Health
Time frame: Baseline, 6 weeks, 12 weeks
Change in SF36 Aggregate Physical (Adjusted Value)
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame: Baseline, 12 weeks
Short Form Health Survey (SF36) Aggregate Physical
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Mean raw scores of SF36 Aggregate Physical.
Time frame: Baseline, 6 weeks, 12 weeks
| Milestone | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Started | 89 | 91 |
| Completed | 81 | 85 |
| Not completed | 8 | 6 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Adverse event | 4 | 4 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Underwent lung transplant | 0 | 1 |
| Milestone | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Started | 79 | 83 |
| Completed | 73 | 70 |
| Not completed | 6 | 13 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Adverse event | 2 | 4 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Underwent lung transplant | 0 | 2 |
This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| participants | Sildenafil | Placebo |
|---|---|---|
| Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement) | 9 | 6 |
The 6MWT measures the distance that a participant can walk in a period of 6 minutes.
| meters | Sildenafil | Placebo |
|---|---|---|
| 1st baseline | 246.93 ± 99.11 | 267.71 ± 127.75 |
| 2nd baseline | 246.39 ± 103.40 | 269.55 ± 129.83 |
| 6 week | 237.29 ± 121.48 | 257.55 ± 139.44 |
| 12 week | 239.09 ± 126.39 | 249.48 ± 138.46 |
The 6MWT measures the distance that a participant can walk in a period of 6 minutes. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| meters | Sildenafil | Placebo |
|---|---|---|
| Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance | -28.5 (-43.2 to -13.8) | -45.2 (-59.7 to -30.8) |
The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis.
| percentage of participants | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Desaturation During 6-minute Walk Test (6MWT) | 83.6 (74.4 to 91.0) | 75.3 (65.3 to 84.3) |
The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in Dyspnea | 0.22 (-3.10 to 3.54) | 6.81 (3.53 to 10.08) |
The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 50.71 ± 22.00 | 43.28 ± 20.18 |
| 6 week | 49.67 ± 22.74 | 47.64 ± 25.61 |
| 12 Week | 50.58 ± 23.41 | 48.13 ± 24.10 |
| Change from Baseline to 6 weeks | -1.27 ± 12.63 | 4.42 ± 17.16 |
| Change from Baseline to 12 weeks | 0.30 ± 16.01 | 6.99 ± 18.43 |
Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| liters | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Change in Forced Vital Capacity (FVC) Adjusted Values | -0.04 (-0.09 to -0.00) | -0.05 (-0.10 to -0.01) |
Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups
| liters | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Baseline | 2.25 ± 0.70 | 2.42 ± 0.75 |
| Week 6 | 2.25 ± 0.72 | 2.40 ± 0.74 |
| Week 12 | 2.22 ± 0.75 | 2.36 ± 0.78 |
| Change from baseline to 6 weeks | -0.03 ± 0.21 | -0.03 ± 0.15 |
| Change from baseline to 12 weeks | -0.04 ± 0.23 | -0.05 ± 0.20 |
Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| percentage of predicted (DLCO) | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values | -0.30 (-1.4 to 0.7) | -1.9 (-2.9 to -0.8) |
Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups
| percentage of predicted (DLCO) | Sildenafil / Sildenafil | Placebo / Sildenafil |
|---|---|---|
| Baseline | 25.81 ± 6.03 | 26.73 ± 6.16 |
| Week 6 | 26.00 ± 7.05 | 26.11 ± 6.28 |
| Week 12 | 25.66 ± 6.79 | 25.38 ± 7.43 |
| Change from baseline to 6 weeks | -0.07 ± 4.35 | -1.15 ± 4.59 |
| Change from baseline to 12 weeks | -0.33 ± 4.58 | -1.78 ± 6.32 |
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values) | 0.04 (-0.30 to 0.37) | 0.37 (0.04 to 0.70) |
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 3.72 ± 1.79 | 3.23 ± 1.80 |
| 6 week | 3.53 ± 1.91 | 3.42 ± 1.79 |
| 12 week | 3.76 ± 2.22 | 3.49 ± 1.61 |
| Change from Baseline to 6 week | -0.23 ± 1.37 | 0.37 ± 1.42 |
| Change from Baseline to 12 week | 0.09 ± 1.62 | 0.39 ± 1.70 |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values) | -1.6 (-3.9 to 0.6) | 2.5 (0.2 to 4.7) |
Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.)
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 54.55 ± 16.46 | 51.72 ± 15.86 |
| 6 week | 52.56 ± 16.81 | 51.74 ± 16.45 |
| 12 Week | 52.58 ± 16.35 | 52.19 ± 16.26 |
| Change from Baseline to 6 weeks | -1.45 ± 10.11 | 1.65 ± 10.53 |
| Change from Baseline to 12 weeks | -1.71 ± 12.35 | 2.88 ± 10.61 |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value | -3.6 (-7.0 to -0.1) | 2.2 (-1.3 to 5.6) |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 58.20 ± 17.75 | 53.99 ± 18.90 |
| 6 week | 55.89 ± 17.72 | 56.26 ± 18.77 |
| 12 Week | 54.49 ± 17.59 | 55.55 ± 19.08 |
| Change from Baseline to 6 weeks | -2.05 ± 16.72 | 3.15 ± 16.30 |
| Change from Baseline to 12 weeks | -3.57 ± 17.95 | 2.80 ± 14.74 |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value | -1.2 (-3.7 to 1.4) | 2.5 (0.0 to 5.0) |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 71.20 ± 17.50 | 68.02 ± 17.63 |
| 6 week | 69.95 ± 18.66 | 67.44 ± 18.51 |
| 12 Week | 69.75 ± 18.63 | 69.13 ± 19.34 |
| Change from Baseline to 6 weeks | -1.95 ± 10.82 | 0.28 ± 10.87 |
| Change from Baseline to 12 weeks | -1.25 ± 12.56 | 2.77 ± 13.27 |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value | -0.9 (-3.8 to 2.0) | 2.8 (-0.0 to 5.7) |
The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 43.20 ± 19.26 | 39.77 ± 18.81 |
| 6 week | 41.62 ± 19.49 | 41.58 ± 19.68 |
| 12 Week | 41.95 ± 19.23 | 41.05 ± 18.81 |
| Change from Baseline to 6 weeks | -0.67 ± 12.79 | 2.37 ± 12.94 |
| Change from Baseline to 12 weeks | -0.91 ± 15.90 | 3.15 ± 13.11 |
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in ICECAP-O Adjusted Value | 0.00 (-0.02 to 0.03) | -0.02 (-0.04 to 0.00) |
The ICEpop CAPability measure for Older people (ICECAP-O) is a measure of capability in older people for use in economic evaluation. The values of ICECAP-O range from 0 (worst) to 1 (best). Mean raw scores of ICECAP-O.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 0.79 ± 0.14 | 0.81 ± 0.13 |
| 6 week | 0.80 ± 0.16 | 0.76 ± 0.17 |
| 12 Week | 0.79 ± 0.14 | 0.81 ± 0.14 |
| Change from Baseline to 6 weeks | 0.02 ± 0.12 | -0.05 ± 0.12 |
| Change from Baseline to 12 weeks | 0.00 ± 0.11 | -0.02 ± 0.10 |
The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in EuroQOL Thermometer (Adjusted Value) | 0.5 (-3.1 to 4.1) | -1.8 (-5.3 to 1.7) |
The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicate a better health state. Mean raw scores of EuroQOL Thermometer.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 66.49 ± 17.45 | 67.66 ± 16.98 |
| 6 week | 69.47 ± 16.92 | 67.09 ± 19.65 |
| 12 Week | 66.96 ± 16.45 | 67.05 ± 16.37 |
| Change from Baseline to 6 weeks | 2.51 ± 15.32 | -1.40 ± 17.23 |
| Change from Baseline to 12 weeks | 0.49 ± 17.28 | -2.12 ± 19.08 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in EuroQOL (EQ-5D) Utility - Adjusted Value | -0.01 (-0.06 to 0.03) | -0.03 (-0.08 to 0.01) |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state. Mean raw scores of EuroQOL Utility.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 0.71 ± 0.24 | 0.74 ± 0.19 |
| 6 week | 0.75 ± 0.23 | 0.71 ± 0.25 |
| 12 Week | 0.70 ± 0.26 | 0.72 ± 0.21 |
| Change from Baseline to 6 weeks | 0.04 ± 0.18 | -0.02 ± 0.24 |
| Change from Baseline to 12 weeks | -0.01 ± 0.23 | -0.03 ± 0.19 |
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in Short Form Health Survey (SF36) General Health - Adjusted Value | -1.0 (-2.5 to 0.4) | -3.9 (-5.4 to -2.4) |
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Mean raw scores of SF36 General Health
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | 36.99 ± 9.64 | 37.66 ± 8.73 |
| 6 week | 36.00 ± 9.85 | 34.97 ± 8.64 |
| 12 Week | 36.31 ± 8.91 | 34.39 ± 8.41 |
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Values adjusted for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Change in SF36 Aggregate Physical (Adjusted Value) | -0.5 (-1.9 to 0.8) | -0.4 (-1.7 to 1.0) |
The SF36 measures functional health and well-being scores on eight scales that correlate with two aggregate scores. Each score ranges from 0 to 100, with a higher score indicating better function. Mean raw scores of SF36 Aggregate Physical.
| units on a scale | Sildenafil | Placebo |
|---|---|---|
| Baseline | -1.68 ± 0.92 | -1.52 ± 0.87 |
| 6 week | -1.70 ± 0.99 | -1.58 ± 0.91 |
| 12 Week | -1.71 ± 0.86 | -1.51 ± 0.89 |
| Change from Baseline to week 6 | -0.06 ± 0.52 | -0.08 ± 0.64 |
| Change from Baseline to week 12 | -0.05 ± 0.56 | -0.05 ± 0.63 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sildenafil | — | 13/89 (14.6%) | 72/89 (80.9%) |
| Placebo | — | 15/91 (16.5%) | 62/91 (68.1%) |
| Event | Sildenafil | Placebo |
|---|---|---|
| Respiratory, thoracic, or mediastinal disorderRespiratory, thoracic and mediastinal disorders | 7/89 | 9/91 |
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 2/89 | 5/91 |
| Infection or infestationInfections and infestations | 3/89 | 2/91 |
| Cardiac disorderCardiac disorders | 1/89 | 3/91 |
| GI disorderGastrointestinal disorders | 2/89 | 1/91 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/89 | 1/91 |
| PneumoniaInfections and infestations | 2/89 | 1/91 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/89 | 2/91 |
| Atrial fibrillationCardiac disorders | 0/89 | 2/91 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/89 | 0/91 |
| Event | Sildenafil | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 18/89 | 17/91 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 13/89 | 13/91 |
| DiarrhoeaGastrointestinal disorders | 12/89 | 8/91 |
| CoughRespiratory, thoracic and mediastinal disorders | 10/89 | 7/91 |
| Oedema peripheralGeneral disorders | 9/89 | 8/91 |
| DizzinessNervous system disorders | 8/89 | 5/91 |
| Upper respiratory tract infectionInfections and infestations | 7/89 | 7/91 |
| BronchitisInfections and infestations | 1/89 | 6/91 |
| HypotensionVascular disorders | 5/89 | 2/91 |
| Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders | 2/89 | 5/91 |
| Age, Continuous(years) | Sildenafil | Placebo | Total |
|---|---|---|---|
| Mean | 69.8 ± 8.7 | 68.2 ± 9.3 | 69.0 ± 8.9 |
| Sex: Female, Male(Participants) | Sildenafil | Placebo | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 75 | 75 | 150 |
| Region of Enrollment(participants) | Sildenafil | Placebo | Total |
|---|---|---|---|
| United States | 89 | 91 | 180 |
The record gives a start of Aug 2007, a primary completion of May 2009 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 4 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sildenafil