Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
ibuprofen
Maladies du système digestif+9
+ Maladies du nouveau-né
+ Maladies pulmonaires
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1996
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period. The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.75 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 5 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers --Prior/Concurrent Therapy-- At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, macrolide antibiotics) --Patient Characteristics-- Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over Hematopoietic: No significant history of hematologic disease Hepatic: No significant history of hepatic disease Renal: No significant history of renal disease Cardiovascular: No significant history of cardiovascular disease Pulmonary: See Disease Characteristics Neurologic: No significant history of neurologic disease Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free of any acute illness within 14 days; No prior hypersensitivity to any NSAID