EVALUATE ANTI-INFLAMMATORY AGENTS IN PATIENTS WITH CYSTIC FIBROSIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a three-arm, multicenter, randomized, open-label, controlled, parallel-group trial comparing the effects of 28 days of Ibuprofen, Celecoxib, or no treatment on inflammatory markers in induced sputum obtained from subjects, 2 > to age 10, with mild to moderate cystic fibrosis (CF). This study will measure changes in markers of lower airway inflammation in samples of induced sputum obtained before (Baseline Period), during (Treatment Period), and after (Recovery Period) treatment with Ibuprofen or Celecoxib in subjects with CF, and compare these changes with those observed in a control group of CF subjects who receive no anti-inflammatory treatment. The purpose for including the no treatment group is to define the variability of measurements performed on samples obtained by Sputum Induction (SI) and to serve as a control group for the Ibuprofen and Celecoxib treatment arms. The primary purpose of this study is to access that an SI proves to be a viable method of measuring the effectiveness of anti-inflammatory agents in patients with mild to moderate CF. The secondary purpose is to determine the benefit of the anti-inflammatory agent, Celecoxib -- Whether this drug's anti-inflammatory properties in the CF lung are similar to those of Ibuprofen. Third, data banking is an ancillary component of this protocol. Upon the particpant's consent, health care information about the participant will be entered into a study database. Data from all centers participating in the Therapeutic Development Network (TDN) will be collecting data from this study to be used at a later time.