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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa; MedDRA version: 20.0Level: LLTClassification code 10068288Term: Cystic fibrosis pulmonary exacerbationSystem Organ Class: 100000113915

• Registration Number: EUCTR2016-002749-42-ES
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Study Completion: 2021-09-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

1) Male or female aged 3 months to less than 18 years at screening
2) Diagnosis of CF as determined by the 2008 CF Consensus Conference criteria
3) Documented new onset of positive respiratory tract culture for PA within 30 days of Screening 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)
4) FEV1 = 80% predicted
5) Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization
6) A negative serum pregnancy test is required for female subjects of child bearing potential who have a positive urine pregnancy test at screening
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8) Lactating females must agree to discontinue nursing before administration of study drug
9) Subjects and/or parent/guardian must be able to give written informed consent prior to study related procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
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

1) Use of IV or inhaled antipseudomonal antibiotics within 2 years of Screening
2) Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (Screening visit)
3) History of intolerance to inhaled short acting ß2 agonists
4) History of lung transplantation
5) Administration of any investigational drug or device within 28 days prior to Screening
6) Concurrent use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone per day or 20 mg prednisone every other day
7) Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
8) Hospitalization for a respiratory event within 30 days prior to Screening
9) Changes in antimicrobial, bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to Screening
10) Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to Screening
11) Abnormal hepatic or renal function results at most recent test within the previous 12 months, defined as
- AST or ALT >5 times upper limit of normal (ULN), or
- Serum creatinine > 2 times ULN for age
12) Presence of a condition or abnormality that would, in the opinion of the Investigator, compromise the subject’s safety or the quality of the study data
13) Known hypersensitivity to aztreonam, its metabolites, or formulation excipients present in AZLI
14) Respiratory cultures performed within 2 years prior to Screening that are positive for ANY Burkholderia spp. or NTM

Study & Design

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