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

• Conditions: Cystic fibrosis and new onset lower respiratory tract culture positive for 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: EUCTR2011-001255-36-IE
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-24
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Males or females aged 3 months to less than 18 years.
• Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria:Documented sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis
test OR Abnormal nasal transepithelial potential difference test OR Two well-characterized, disease-causing genetic mutations in the CF transmembrane
conductance regulator (CFTR) gene AND One 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 patients = 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.
• All sexually active female subjects who are of childbearing potential must agree to use a
highly effective method of contraception during heterosexual intercourse throughout the
study. Females utilizing hormonal contraceptives as a birth control method must have
used the same method for at least 3 months prior to study drug dosing.
• Male subjects must agree to use barrier contraception (condom with spermicide) during
heterosexual intercourse from screening through to study completion and for 90 days
from the last dose of study investigational medicinal product.
• Subjects and/or parent/guardian must be able to give written informed consent prior to
any study related procedure.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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 sputum or throat swab culture yielding Burkholderia spp. within 2 years prior
to screening visit
• History of local or systemic hypersensitivity to monobactam antibiotics
• History of intolerance to inhaled short acting ß2 agonists
• History of lung transplantation
• History of AZLI (or Cayston®) administration
• Administration of any investigational drug or device within 28 days prior to Screening
Visit or within 6 half-lives of the investigational drug (whichever is longer)
• Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone
per day or 20 mg prednisone every other day
• Current requirement for daily continuous oxygen supplementation or requirement of
more than 2 L/minute at night
• Hospitalization for pulmonary-related illness within 28 days prior to Screening Visit
• Changes in or initiation of chronic azithromycin treatment within 28 days prior to
Screening Visit
• Changes in antimicrobial, bronchodilator (BD), corticosteroid, dornase alfa, or hypertonic
saline medications within 7 days prior to Screening Visit; for subjects on a stable regimen
of hypertonic saline (28 days on/28 days off), beginning or ending a cycle of hypertonic
saline is allowed
• Changes in physiotherapy technique or schedule within 7 days prior to Screening Visit
• Abnormal renal or hepatic 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
• Pregnant or lactating females; a negative urine pregnancy test is required for all female
subjects of childbearing potential (unless surgically sterile), and confirmatory serum
pregnancy test in the event of an initial positive urine test result
• Any serious or active medical or psychiatric illness (including drug or alcohol abuse),
which in the opinion of the investigator, would interfere with subject treatment,
assessment, or compliance with the protocol
• Presence of a condition or abnormality that would compromise the patient’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