Hydroxychloroquine in Cystic Fibrosis

NCT00311883 | Completed Phase 1 DMC

• 1 other identifier: 060051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Induced sputum; Lung inflammation

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory mediators and exhaled breath condensate pH following 4 week administration of drug.

  28 days

Interventions

hydroxychloroquine DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pneumonia

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bonnie S Slovis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 6, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 30, 2008

Record last verified: 2008-01

Locations

US (1)