Cystic Fibrosis Clinical Trial
Official title:
The Role of Phosphodiesterase Inhibitors in CF Lung Disease
Verified date | October 2020 |
Source | National Jewish Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Confirmed diagnosis of CF based on the following criteria: - Positive sweat chloride =60mEq/liter (by pilocarpine iontophoresis) and/or - Genotype with two identifiable mutations consistent with CF, and accompanied by one or more clinical features consistent with the CF phenotype - Male or female patients = 12 years of age - FEV1 = 50% predicted (Knudson) 31 - Clinically stable without evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to the screening visit - Ability to reproducibly perform spirometry (according to ATS criteria) - Ability to produce at least 1mL of sputum spontaneously, or be willing to undergo sputum induction - Ability to understand and sign a written informed consent or assent and comply with the requirements of the study - Chronic bacterial colonization (3 documented positive cultures in the prior 2 years of which at least one was obtained in the 3 months prior to randomization) Exclusion Criteria: - History of hypersensitivity to sildenafil - Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0) - Breastfeeding, pregnant, or verbal expression of unwillingness to practice an acceptable birth control method (abstinence, hormonal or barrier methods, partner sterilization or intrauterine device) during participation in the study - Daily use of systemic corticosteroids and/or NSAIDs within 4 weeks of the study or as needed use within 72 hours prior to the screening visit - History of significant hepatic (SGOT or SGPT > 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension), cardiovascular (history of aortic stenosis, coronary artery disease, pulmonary hypertension with right ventricular systolic pressure >55 mmHg or life-threatening arrhythmia), neurological (history of stroke), hematologic (history of bleeding diathesis), ophthalmologic (history of retinal impairment or non-arteritic ischemic optic neuritis) or renal impairment (creatinine >1.8 mg/dL.) - Inability to swallow pills - Previous lung transplantation - Use of concomitant nitrates, a-blocker, or Ca channel blocker - Use of concomitant medications known to be potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin, rifampin) - Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data - Weight less than 40 kg - History of sputum or throat swab culture yielding Burkholderia cepacia within 2 years of screening - Resting room air oxygen saturation <93% - History of migraines |
Country | Name | City | State |
---|---|---|---|
United States | National Jewish Health | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Jewish Health | Cystic Fibrosis Foundation |
United States,
Poschet JF, Timmins GS, Taylor-Cousar JL, Ornatowski W, Fazio J, Perkett E, Wilson KR, Yu HD, de Jonge HR, Deretic V. Pharmacological modulation of cGMP levels by phosphodiesterase 5 inhibitors as a therapeutic strategy for treatment of respiratory pathology in cystic fibrosis. Am J Physiol Lung Cell Mol Physiol. 2007 Sep;293(3):L712-9. Epub 2007 Jun 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sputum Elastase | Pre/post therapy | ||
Secondary | Exhaled Breath Condensate pH | Pre/post therapy | ||
Secondary | CFQ-R | Pre/post therapy | ||
Secondary | Serum Sildenafil Levels | Pre/during therapy |
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