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Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659529
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : May 2, 2014
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Jennifer Brandorff, National Jewish Health

Brief Summary:
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: sildenafil Phase 1 Phase 2

Detailed Description:
This study is an open-label study that examines the use of sildenafil (Revatio) in clinically stable patients with mild to moderate CF lung disease. The length of participation for each subject will be approximately 10 weeks, and will consist of a screening visit, a study visit for initiation of study drug if subject qualifies, interim visits to escalate drug dose, obtain drug levels, review concomitant medications and assess side effects, a visit at the end of the therapy period (to reassess inflammatory markers, laboratory studies and side effects,) and a follow-up assessment 2 weeks after subject completion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Phosphodiesterase Inhibitors in CF Lung Disease
Actual Study Start Date : August 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: 1
All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
Drug: sildenafil
Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.
Other Name: Revatio




Primary Outcome Measures :
  1. Sputum Elastase [ Time Frame: Pre/post therapy ]

Secondary Outcome Measures :
  1. Exhaled Breath Condensate pH [ Time Frame: Pre/post therapy ]
  2. CFQ-R [ Time Frame: Pre/post therapy ]
  3. Serum Sildenafil Levels [ Time Frame: Pre/during therapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, α-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

Information from the National Library of Medicine

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): NCT00659529


Locations
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United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Jennifer L Taylor-Cousar, MD National Jewish Health

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Brandorff, Manager, Clinical Research Services, Regulatory, National Jewish Health
ClinicalTrials.gov Identifier: NCT00659529    
Other Study ID Numbers: 851R14-8510M3
First Posted: April 16, 2008    Key Record Dates
Results First Posted: May 2, 2014
Last Update Posted: April 26, 2017
Last Verified: March 2017
Keywords provided by Jennifer Brandorff, National Jewish Health:
cystic fibrosis
inflammation
pH
EBC
sputum biomarkers
phosphodiesterase inhibitors
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Sildenafil Citrate
Phosphodiesterase Inhibitors
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents