Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis,...
Cystic FibrosisLung Infection1 moreThe purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second [FEV1] >75% predicted, and Pseudomonas aeruginosa (PA) infection.
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Cystic FibrosisThe purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.
The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis
Cystic FibrosisThis study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency...
Cystic FibrosisPancreatic Exocrine InsufficiencyThis study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients
Cystic FibrosisVitamin D DeficiencyThe main aim of the research question to test the primary hypothesis of this study, namely, Does 12 weeks of an additional 5000 IU daily of cholecalciferol increase serum 25OHD levels in adults with Cystic Fibrosis (CF) who have vitamin D deficiency relative to placebo?
Second Open Label Extension to Bridging Study CTBM100C2303
Pulmonary InfectionsPseudomonas AeruginosaThis was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis...
Cystic FibrosisCystic Fibrosis (CF) is an inherited disorder in which mucus-secreting glands in the lungs produce considerable quantity of thick, sticky secretions that clog the airways, promote bacterial growth and lead to chronic obstruction, inflammation and destruction of the airways. The purpose of this study is to collect data about the resolution of the chronic inflammatory state in addition to assure the safety of the therapy in CF patients.
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to...
Cystic FibrosisThis is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF) and chronic infection due to pseudomonas aeruginosa.
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
Cystic FibrosisThis study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.
Study of VX-770 and Rifampin in Healthy Male Subjects
Cystic FibrosisThe objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.