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

Phase 1

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

• Registration Number: EUCTR2011-001255-36-BE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Aged 3 months to less than 18 years.
• 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 new onset of positive lower respiratory tract culture for PA within 30 days of study entry (screening visit) defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
• FEV1 = 80% predicted (for subjects = 6 years of age).
• 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: 105
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 2 years of study entry (screening visit).
• Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit).
• History of hypersensitivity/adverse reaction to aztreonam, or beta-agonists.
• Use of any investigational drug, or device within 28 days of study entry (screening visit).
• Presence of a condition or abnormality that would compromise the subject's safety or the quality of study data, in the opinion of the investigator.

Study & Design

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