Assessment of Inflammatory Mediators (AIM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00219895 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : December 25, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Ibuprofen | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis |
Study Start Date : | August 2004 |
Actual Study Completion Date : | March 2006 |

- Changes in markers of inflammation in induced sputum samples: total white cell count, total neutrophil count, percent neutrophils, active elastase, and cytokines.
- (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

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female 10 years of age or older.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219895
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35223 | |
United States, California | |
Stanford University - Packard Children's Hospital | |
Palo Alto, California, United States, 94304 | |
University of California - San Diego | |
San Diego, California, United States, 92123 | |
United States, Colorado | |
University of Colorado Health Sciences Center - Children's Hospital | |
Denver, Colorado, United States, 80218 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Harvard University - Children's Hospital of Boston, Pulmonary Division | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
University Of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University - St. Louis Children's Hospital | |
St. Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
University of North Carolina, Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
Case Western Reserve University - Rainbow Babies and Children's Hospital | |
Cleveland, Ohio, United States, 44106 | |
Columbus Children's Hospital | |
Columbus, Ohio, United States, 43205-2696 | |
United States, Texas | |
Baylor College of Medicine - Texas Children's Hospital | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah Health Sciences Center | |
Salt Lake City, Utah, United States, 84132 |
Principal Investigator: | James Chmiel, MD, MPH | Case Western Reserve University - Rainbow Babies and Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00219895 |
Other Study ID Numbers: |
CFOM0003 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | December 25, 2007 |
Last Verified: | August 2006 |
Cystic Fibrosis Anti-inflammatory Agents Ibuprofen |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Ibuprofen Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |