Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients...
Cystic Fibrosis PatientPatient Without Treatment Against A.FumigatusThe study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis. In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic...
Vitamin D DeficiencyChildren with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study. Upon consent, they will be given oral cholecalciferol supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed by measuring a serum calcium level within 1 week of supplementation. Efficacy will be assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be assessed with the previous two measures as well as a brief questionnaire administered via telephone within 1 week of supplementation.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and...
Cystic FibrosisThis is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial
Cystic FibrosisIn this research study the investigators want to learn more about whether using a fitness tracker and accelerometer helps patients with cystic fibrosis exercise more regularly, and in turn whether it increases exercise tolerance over the period of one year.
A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
Cystic FibrosisThe purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28. Funding Source - FDA OOPD
Saline Hypertonic in Preschoolers
Cystic FibrosisThe purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks improves the lung clearance index by multiple breath nitrogen washout in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 5) with cystic fibrosis.
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic...
Cystic FibrosisThis is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.
EASY: Extended Access to Sollpura Over Years
Exocrine Pancreatic InsufficiencyCystic FibrosisLiprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice.
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and...
Cystic FibrosisHomozygous for the F508del CFTR MutationThe primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin...
Cystic FibrosisThe purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.