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Sponsors and Collaborators: |
Ramsey, Bonnie, MD Cystic Fibrosis Foundation |
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Information provided by: | Ramsey, Bonnie, MD |
ClinicalTrials.gov Identifier: | NCT00219895 |
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.
Condition | Intervention |
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Cystic Fibrosis |
Drug: Ibuprofen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis |
Estimated Enrollment: | 120 |
Study Start Date: | August 2004 |
Study Completion Date: | March 2006 |
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 with CF has shown clinical benefit, but adverse effects and other considerations have markedly limited their use. Therefore, alternative anti-inflammatory agents are urgently needed. Results from the clinical trials of alternate-day corticosteroids and high-dose ibuprofen in CF indicate that anti-inflammatory therapy will probably not result in improvement in pulmonary function, but will slow the rate of decline. This expectation imposes constraints on the design of studies to test new anti-inflammatory agents, requiring that they use many patients over a considerable period of time (years, rather than the months that are necessary to evaluate anti-infective or anti-obstructive therapies). Thus, it is highly desirable to design a strategy for evaluation of prospective anti-inflammatory agents that will allow for the selection of only the most promising agents for further study in Phase III type trials. Of additional concern is the fact that some pharmaceutical firms have not pursued development of anti-inflammatory agents for CF because there were no early indicators of efficacy. This presents an insurmountable hurdle for translation of research advances into clinical treatments. Some means of screening candidate drugs is urgently required. This study will assess the measurement of inflammatory mediators in induced sputum as one such strategy. The hypothesis to be tested is that ibuprofen will reduce neutrophils, active elastase, and pro-inflammatory cytokines in induced sputum after 4 weeks of therapy in patients with CF.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Confirmed diagnosis of CF based on the following criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35223 | |
United States, California | |
University of California - San Diego | |
San Diego, California, United States, 92123 | |
Stanford University - Packard Children's Hospital | |
Palo Alto, California, United States, 94304 | |
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 | |
Harvard University - Children's Hospital of Boston, Pulmonary Division | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
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 | |
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 | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
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 |
Study ID Numbers: | CFOM0003 |
Study First Received: | September 16, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00219895 History of Changes |
Health Authority: | United States: Institutional Review Board |
Cystic Fibrosis Anti-inflammatory Agents Ibuprofen |
Anti-Inflammatory Agents Ibuprofen Fibrosis Cyclooxygenase Inhibitors Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn |
Analgesics, Non-Narcotic Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Ibuprofen Molecular Mechanisms of Pharmacological Action Fibrosis Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis Respiratory Tract Diseases |
Genetic Diseases, Inborn Sensory System Agents Analgesics, Non-Narcotic Lung Diseases Therapeutic Uses Pancreatic Diseases Infant, Newborn, Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |