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Cystic Fibrosis


Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis PDF Print E-mail
To evaluate the change in forced expiratory volume (FEV1) from baseline to Day 28-30 between Cipro Inhale-treated and placebo-treated subjects after a 4-week treatment period. This study is evaluating both children 12- 17 years of age and adults.
 
Aztreonam for Inhalation Solution (AZLI) vs Tobramycin Inhalation Solution (TOBI®) in Patients With CF & P. Aeruginosa PDF Print E-mail

The purpose of this study is to assess the comparative safety and effectiveness of Aztreonam for Inhalation Solution versus Tobramycin Nebuliser Solution in adult and pediatric patients with CF and pulmonary Pseudomonas aeruginosa (PA) infection.

 
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis PDF Print E-mail
  • This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
  • For adults 18 years of age and greater
 
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis PDF Print E-mail
  • This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
  • For Children up to 18 years of age.
 
Study Investigating a Delayed-Release Pancrelipase in Patients w/ Exocrine Pancreatic Insufficiency PDF Print E-mail
  • This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
 
Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation PDF Print E-mail
  • A major factor in the respiratory health of CF subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (ArikaceTM) is a sustained-release formulation of amikacin encapsulated inside nanoscale liposomal carriers designed for administration via inhalation. It is hypothesized that the sustained-release pulmonary targeting and biofilm penetration properties of this formulation will have several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.

 

 
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules PDF Print E-mail
  • The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).