Phase 3
N=51
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Bottom Line
View on ClinicalTrials.gov: NCT01082367 ↗Enrolled (actual)
51
Serious AEs
3.9%
Results posted
Apr 2016
Primary outcome: Primary: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle — 84.6; 24.0 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TOBI (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle |
84.6; 24.0 | <0.001 sig |
| SECONDARY Percentage of Participants Free From P. Aeruginosa 28 Days After Termination of the Second Treatment Cycle |
92.3; 83.3 | — |
| SECONDARY Percentage of Participants P Aeruginosa-free at Termination of the Double Blind Period |
76.0; 47.8 | — |
Summary
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01082367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.