Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria

Phase 1

• Conditions: cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa; MedDRA version: 14.1Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10070608Term: Infective pulmonary exacerbation of cystic fibrosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001362-18-FR
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Aged 12 years or less.
• Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: sweat chloride level = 60 mEq/L by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF.
• Documented positive lower respiratory tract culture for PA at the screening visit plus 2 documented positive lower respiratory tract cultures for PA within 12 months prior to study entry (start of treatment).
• Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Use of IV or inhaled antipseudomonal antibiotics within 14 days of study entry (start of treatment).
• Presence of a condition or abnormality that would compromise the participant’s safety or the quality of study data, in the opinion of the investigator.
• History of hypersensitivity/adverse reaction to aztreonam or beta-agonists.
• Use of any investigational drug within 30 days of study entry (start of treatment).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for 3 courses of therapy (28 days on/28 days off) in female and male children less than 13 years of age with CF and chronic PA infection/colonization.;Secondary Objective: N/A;Primary end point(s): Percentage of subjects who have discontinued the study drug due to safety or tolerability reasons by Day 168.;Timepoint(s) of evaluation of this end point: Between baseline (Day 1) and Day 168.