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Sponsored by: |
University of New Mexico |
Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00659529 |
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.
Condition | Intervention | Phase |
Cystic Fibrosis |
Drug: sildenafil |
Phase I Phase II |
Genetics Home Reference related topics: | cystic fibrosis |
MedlinePlus related topics: | Cystic Fibrosis |
ChemIDplus related topics: | Sildenafil citrate Sildenafil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | The Role of Phosphodiesterase Inhibitors in CF Lung Disease |
Estimated Enrollment: | 20 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Placebo/sildenafil Subjects will be randomized to receive the following treatment sequence: placebo/sildenafil or sildenafil/placebo. A 28-day washout period will proceed entrance into the 2nd treatment sequence.
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Drug: sildenafil
Sildenafil or placebo will be given 20mg po tid for 28 days.
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2: Experimental
Sildenafil/placebo Subjects will be randomized to receive the following treatment sequence: placebo/sildenafil or sildenafil/placebo. A 28-day washout period will proceed entrance into the 2nd treatment sequence.
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Drug: sildenafil
Sildenafil or placebo will be given 20mg po tid for 28 days.
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This study is a placebo-controlled, double blind cross-over study of (sildenafil) Revatio® in clinically stable patients with mild to moderate CF lung disease. The length of participation for each subject will be approximately 14 weeks, and will consist of a screening visit, two in-patient study visits with initiation of study drug and/or placebo, two interim visits during therapy, two visits at end of each therapy period (to reassess inflammatory markers, pulmonary function, laboratory studies and side effects,) a 28-day washout period with coordinator phone call, and a follow-up assessment 2 weeks after subject completion.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmed diagnosis of CF based on the following criteria:
Exclusion Criteria:
Contact: Jolene Vigil, BA/BS | 505-272-6955 | jolvigil@salud.unm.edu |
United States, New Mexico | |||||
Univeristy of New Mexico Health Sciences Center | Not yet recruiting | ||||
Albuquerque, New Mexico, United States, 87131 | |||||
Principal Investigator: Jennifer L Taylor-Cousar, MD | |||||
Sub-Investigator: Charles Gallegos, NP |
University of New Mexico |
Principal Investigator: | Jennifer L Taylor-Cousar, MD | University of New Mexico |
Responsible Party: | University of New Mexico Health Sciences Center ( Jennifer Taylor-Cousar, MD Associate CF Center/Adult CF Program Director ) |
Study ID Numbers: | 851R14-8510M3 |
First Received: | April 14, 2008 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00659529 |
Health Authority: | United States: Institutional Review Board |
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