Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CF
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|ClinicalTrials.gov Identifier: NCT02626182|
Recruitment Status : Completed
First Posted : December 10, 2015
Results First Posted : July 15, 2019
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: sildenafil Drug: placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe Cystic Fibrosis Lung Disease|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 18, 2018|
|Actual Study Completion Date :||January 29, 2018|
Subjects will be randomized in a 3:1 (sildenafil:placebo) fashion. Subjects randomized to the treatment arm will receive sildenafil 20 mg p.o. t.i.d for 1 week followed by 40 mg p.o. t.i.d. for 11 weeks.
Other Name: Revatio, Viagra
Placebo Comparator: Placebo
Subjects randomized to the placebo arm will receive placebo p.o. t.i.d for 1 week followed by 2 placebo tablets p.o. t.i.d. for 11 weeks.
sugar pill that looks like sildenafil tablets
- 6 Minute Walk Distance [ Time Frame: Weeks 1, 13 ]Change in distance walked between week 1 and week 13 were compared. The difference between the two time points is reported.
- Cardiopulmonary Exercise Test Work Rate [ Time Frame: Weeks 1 and 13 ]Work rate (the amount of energy being expended to cycle) was assessed at weeks 1 and 13. The change in maximum work measured during CPET between weeks 1 and 13 is reported.
- Cystic Fibrosis Quality of Life-Revised Respiratory Domain Score [ Time Frame: Assessed at weeks 1 and 13 ]The CFQ-R Respiratory domain score (scale 0-100 with higher scores indicating better quality of life) was assessed at weeks 1 and 13. The change in the score between week 1 and week 13 is reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626182
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||Jennifer L Taylor-Cousar, MD||National Jewish Health|