Assessment of Inflammatory Mediators (AIM)

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00219895

Run by

Ramsey, Bonnie, MD

People needed

120

Starts

2004-08-01

Expected to finish

2006-03-01

Last updated by the study team

2007-12-25

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University - Packard Children's Hospital — Palo Alto, California, United States
• University of California - San Diego — San Diego, California, United States
• University of Colorado Health Sciences Center - Children's Hospital — Denver, Colorado, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Harvard University - Children's Hospital of Boston, Pulmonary Division — Boston, Massachusetts, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Washington University - St. Louis Children's Hospital — St Louis, Missouri, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University - Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Columbus Children's Hospital — Columbus, Ohio, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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