Status:
COMPLETED
Assessment of Inflammatory Mediators (AIM)
Lead Sponsor:
Ramsey, Bonnie, MD
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10+ years
Phase:
NA
Brief 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 ...
Detailed Description
Inflammation clearly contributes to the progression of cystic fibrosis (CF) lung disease. Anti-inflammatory therapy with alternate-day corticosteroids and twice-daily high-dose ibuprofen in patients w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00219895
Start Date
August 1 2004
End Date
March 1 2006
Last Update
December 25 2007
Active Locations (16)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
2
Stanford University - Packard Children's Hospital
Palo Alto, California, United States, 94304
3
University of California - San Diego
San Diego, California, United States, 92123
4
University of Colorado Health Sciences Center - Children's Hospital
Denver, Colorado, United States, 80218