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EAP Overview

The Aztreonam Lysine for Inhalation Expanded Access Program (EAP) is open to all treatment centers in the U.S. Through the program, eligible cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa, who have limited or no treatment options, and who are at risk for disease progression, may gain access to aztreonam lysine for inhalation (75 mg) prior to FDA approval. Below is a synopsis of the EAP protocol.

EAP DESIGN
Open-label, expanded access program of aztreonam lysine for inhalation (75 mg) three times daily. No formal hypothesis testing is planned for this program. Efficacy will not be examined. Serious adverse events (SAE) will be collected.
Number of subjects planned:
U.S. patients who meet entry criteria are eligible to enroll. Entry criteria will be broadened in defined stages to allow additional access to the investigational drug.
Target population:
See Patient Entry Criteria section.
Duration of treatment:
Eligible patients who enroll will receive open-label aztreonam lysine for inhalation (75 mg), three times daily until: voluntary withdrawal from the program; the investigator feels it is in the best interest of the patient to be withdrawn; death; FDA approval; or Gilead terminates the program.
EAP procedures/frequency:
Patients will be evaluated by the prescribing physician (investigator) at Screening, Baseline, Day 28, Day 56 and every two months thereafter until the discontinuation of aztreonam lysine for inhalation. At each visit, drug accountability (how many vials used/unused) and safety data will be collected and reported on case report forms.

Patients who discontinue for any reason must return 30 days following discontinuation for a final program evaluation visit. Additional follow-up should occur at the investigator's discretion.
TEST PRODUCT, DOSE AND MODE OF ADMINISTRATION
Aztreonam lysine for inhalation (75 mg aztreonam as the lysine salt) will be administered via the investigational PARI eFlow® Electronic Nebulizer. Recommended dosage is three times daily. Drug and nebulizer will be provided at no cost for the duration of the program.
CRITERIA FOR EVALUATION
 
Safety:
Serious adverse events will be collected.
Efficacy:
Efficacy will not be examined in this program.

This EAP will be conducted in accordance with the guidelines of Good Clinical Practices (GCPs), including archiving essential documents.

Next: Learn more about expanded access programs