Assessment of Inflammatory Mediators (AIM)
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Anti-inflammatory Agents, Ibuprofen
Eligibility Criteria
Inclusion Criteria: Male or female 10 years of age or older. Confirmed diagnosis of CF based on the following criteria: positive sweat chloride >= 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF, and accompanied by one or more clinical features consistent with the CF phenotype FEV1 >= 50% predicted value (subjects >= 10 - <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 Exclusion Criteria: Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0) Chronic daily use of ibuprofen, celecoxib, or other selective COX-2 inhibitors, other NSAIDs, or systemic or inhaled corticosteroids within the 4 weeks prior to Visit 1 (Day 0) or acute usage within 72 hours prior to Visit 1 (Day 0) History of hypersensitivity to beta-agonists History of hypersensitivity to sulfonamides, aspirin, or other NSAIDs Oxygen saturation < 92% on room air at Visit 1 (Day 0) 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 (Day 0) Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease SGOT (ALT) or SGPT (AST) > 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension Creatinine > 1.8 mg/dL at screening Inability to swallow pills 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
Sites / Locations
- University of Alabama at Birmingham
- Stanford University - Packard Children's Hospital
- University of California - San Diego
- University of Colorado Health Sciences Center - Children's Hospital
- University of Iowa
- Johns Hopkins Hospital
- Massachusetts General Hospital
- Harvard University - Children's Hospital of Boston, Pulmonary Division
- University Of Minnesota
- Washington University - St. Louis Children's Hospital
- University of North Carolina, Chapel Hill
- Cincinnati Children's Hospital Medical Center
- Case Western Reserve University - Rainbow Babies and Children's Hospital
- Columbus Children's Hospital
- Baylor College of Medicine - Texas Children's Hospital
- University of Utah Health Sciences Center