Assessment of Inflammatory Mediators (AIM)
Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis
1 other identifier
interventional
120
1 country
16
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2004
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 25, 2007
August 1, 2006
September 16, 2005
December 18, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in markers of inflammation in induced sputum samples: total white cell count, total neutrophil count, percent neutrophils, active elastase, and cytokines.
Secondary Outcomes (1)
(1) Alterations in laboratory evaluations: CBC, ESR, CRP, serum chemistry profile, urinalysis, and spirometry. (2) Adverse events associated with sputum induction or administration of study medications
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsey, Bonnie, MDlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35223, United States
Stanford University - Packard Children's Hospital
Palo Alto, California, 94304, United States
University of California - San Diego
San Diego, California, 92123, United States
University of Colorado Health Sciences Center - Children's Hospital
Denver, Colorado, 80218, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Harvard University - Children's Hospital of Boston, Pulmonary Division
Boston, Massachusetts, 02115, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
Washington University - St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Case Western Reserve University - Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Columbus Children's Hospital
Columbus, Ohio, 43205-2696, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Chmiel, MD, MPH
Case Western Reserve University - Rainbow Babies and Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
August 1, 2004
Study Completion
March 1, 2006
Last Updated
December 25, 2007
Record last verified: 2006-08