Hydroxychloroquine in Cystic Fibrosis
Completed · Phase 1
Conditions studied: Cystic Fibrosis
In brief
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.
Key facts
- Study ID
- NCT00311883
- Run by
- Vanderbilt University
- People needed
- 20
- Starts
- 2006-03-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2008-01-30
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female between 16 years and 65 years of age.
- Confirmed diagnosis of CF based on the following criteria:
- i. positive sweat chloride 60 mEq/liter (by pilocarpine iontophoresis) and/or ii. a genotype with two identifiable mutations consistent with CF, and iii. accompanied by one or more clinical features consistent with the CF phenotype
- FEV1 50% predicted value (subjects 16- <18 years of age) or 40% predicted value (subjects 18 years of age)
- Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
- Ability to reproducibly perform spirometry and peak flow measurements
- Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
You may not qualify if…
- Use of an investigational agent within the 4-week period prior to Visit 1
- Chronic daily use of ibuprofen or other NSAIDs, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to Visit 1 or acute usage within 72 hours prior to Visit 1
- History of hypersensitivity to beta-agonists
- History of hypersensitivity to hydroxychloroquine or chloroquine
- Oxygen saturation < 92% on room air at Visit 1
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- History of hemoptysis 30 cc per episode during the 30 days prior to Visit 1
- Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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