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Hydroxychloroquine in Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311883
First Posted: April 6, 2006
Last Update Posted: January 30, 2008
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.
Information provided by:
Vanderbilt University
  Purpose
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
Cystic Fibrosis Drug: hydroxychloroquine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug. [ Time Frame: 28 days ]

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)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between 16 years and 65 years of age.
  2. 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

  3. FEV1 50% predicted value (subjects 16- <18 years of age) or 40% predicted value (subjects 18 years of age)
  4. 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)
  5. Ability to reproducibly perform spirometry and peak flow measurements
  6. Ability to understand and sign a written informed consent or assent and comply with the requirements of the study

Exclusion Criteria:

  1. Use of an investigational agent within the 4-week period prior to Visit 1
  2. 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
  3. History of hypersensitivity to beta-agonists
  4. History of hypersensitivity to hydroxychloroquine or chloroquine
  5. Oxygen saturation < 92% on room air at Visit 1
  6. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  7. History of hemoptysis 30 cc per episode during the 30 days prior to Visit 1
  8. Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
  Contacts and Locations
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): NCT00311883


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Bonnie S Slovis, MD Vanderbilt University
  More Information

Responsible Party: Bonnie Slovis, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00311883     History of Changes
Other Study ID Numbers: 060051
First Submitted: April 4, 2006
First Posted: April 6, 2006
Last Update Posted: January 30, 2008
Last Verified: January 2008

Keywords provided by Vanderbilt University:
Cystic Fibrosis
Induced sputum
Lung inflammation

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents