Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years (EARLY)

Novartis

Status and phase: Completed; Phase 3

Conditions: Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients

Treatments: Drug: Placebo; Drug: TOBI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082367

CTBM100C2304

2009-016590-15 (EudraCT Number)

Details and patient eligibility

About

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Enrollment: 50 patients

Sex: All

Ages: 3 months to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

TOBI (tobramycin inhaled solution)/Placebo

Experimental group

Description:

Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle).

Treatment:

Drug: Placebo

Drug: TOBI

Placebo/TOBI

Placebo Comparator group

Description:

Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle).

Treatment:

Drug: Placebo

Drug: TOBI