Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 4/13/2015 |
| Start Date: | April 2010 |
| End Date: | September 2015 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years
This study will investigate the efficacy of inhaled TOBI treatment for early infections of
P. aeruginosa in paediatric patients with cystic fibrosis.
P. aeruginosa in paediatric patients with cystic fibrosis.
Inclusion Criteria:
- Diagnosis of cystic fibrosis
- Early lower respiratory tract infection with P. aeruginosa,
Exclusion Criteria:
- Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- Administration of loop diuretics within 7 days prior to study drug administration.
- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
6
sites
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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