Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: > 6years of age Patient has CF as diagnosed by one of the following: - Documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test, or -Two well characterized genetic mutations in the CFTR gene, or - Abnormal nasal potential difference with accompanying symptoms characteristic of CF PA present in expectorated sputum or throat swab culture within 2 months prior to consent Patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure At high risk for disease progression as defined by one of the following patient populations: -First Cohort Criteria: Those who are waitlisted or eligible for lung transplant based on FEV1 criteria. Patients who have a level of lung function impairment consistent with lung transplantation criteria, but who are ineligible for transplantation for other reasons, can enroll in this program. Or Completed participation in CP-Al-006 (through Visit 20). Patients who withdraw from CP-Al-006 prior to completing all courses of AZLI and all study visits will not be eligible for this protocol. - Second Cohort Criteria: Meets first cohort criteria; or FEV1 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements Patients with hypersensitivity to any of the components of the drug product Currently enrolled in another clinical trial Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation 75 mng prior to its commercial availability to patients with cystic fibrosis and chronic P. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.;Secondary Objective: Not applicable;Primary end point(s): Not applicable: Expanded Access Program;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactClinical Trials Information
Gilead Sciences International Ltd
Outcome results
None listed