Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CF

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This study evaluates the ability of the drug sildenafil to improved exercise capacity, cardiac performance during exercise, and quality of life in patients with moderate to severe CF lung disease. 3/4 of the subjects will receive sildenafil and 1/4 will receive placebo.

Key facts

Study ID

NCT02626182

Run by

National Jewish Health

People needed

14

Starts

2015-12-01

Expected to finish

2018-01-29

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 18 years of age
• FEV1 ≥ 20% predicted and ≤ 70% predicted (Hankinson)
• 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 understand and sign a written informed consent or assent and comply with the requirements of the study
• Willingness to maintain chronic CF medication schedule (e.g. alternating month inhaled antibiotics)

You may not qualify if…

• 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 for women of child-bearing potential.
• History of significant hepatic disease (AST or ALT > 5 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension),
• History of significant cardiovascular disease (history of aortic stenosis, coronary artery disease, or life-threatening arrhythmia),
• History of severe neurological disease (e.g. history of stroke),
• History of severe hematologic disease (e.g. history of bleeding diathesis; current INR > 2.0
• History of severe ophthalmologic disease (e.g. history of retinal impairment or non-arteritic ischemic optic neuritis)
• History of severe renal impairment (creatinine >1.8 mg/dL.)
• Inability to swallow pills
• Previous organ transplantation
• Use of concomitant nitrates, α-blocker, or Ca channel blocker (currently or within one month of Visit 1)
• Use of concomitant medications known to be potent inhibitors of CYP3A4 [e.g. ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin, rifampin (currently or within one month of initiation of study drug)] NOTE: use of azithromycin is NOT a cause for exclusion
• History of sputum or throat swab culture yielding Burkholderia cepacia or Mycobacterium massiliense within 2 years of screening
• Weight less than 40 kg at Screening
• History of migraine headaches.
• Resting room air oxygen saturation <80% without supplemental oxygen
• 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
• Start of CFTR modulator therapy less than 1 month prior to first dose of sildenafil or placebo
• Use of anticoagulants
• Frank pulmonary hypertension (RVSP >40 mmHg by ECHO)

Where it is running

• National Jewish Health — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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