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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00311883 |
Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: hydroxychloroquine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis |
Enrollment: | 20 |
Study Start Date: | March 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate pH in patients with cystic fibrosis.
Patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an FEV1 greater than 40% predicted will be eligible for enrollment. Enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. Inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate pH will be measure at entry and at the end of 4 weeks of oral drug. There will be no placebo group.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Bonnie S Slovis, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Bonnie Slovis, M.D. ) |
Study ID Numbers: | 060051 |
Study First Received: | April 4, 2006 |
Last Updated: | January 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00311883 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cystic Fibrosis Induced sputum Lung inflammation |
Antimalarials Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Hydroxychloroquine Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Antirheumatic Agents Inflammation |
Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Fibrosis Enzyme Inhibitors Pharmacologic Actions Antimalarials Antiparasitic Agents Digestive System Diseases Pathologic Processes |
Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Therapeutic Uses Lung Diseases Hydroxychloroquine Pancreatic Diseases Infant, Newborn, Diseases Antirheumatic Agents |