Assessment of Inflammatory Mediators (AIM)

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Specific Aim: To determine whether neutrophils, active elastase, and cytokines measured in sputum induced using hypertonic saline are useful screening tests for determining if a particular agent with known anti-inflammatory properties is a suitable candidate for more extensive clinical trials in patients with CF. This aim will be addressed using an anti-inflammatory agent, ibuprofen, that has been shown to have clinical benefit in CF. A "no treatment" arm will be included as the control group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ramsey, Bonnie, MD
• Collaborators: Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics
• Treatments: Anti-Inflammatory Agents; Ibuprofen

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