Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF (AZLI CAT)

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: AZLI; Drug: Placebo to match AZLI; Drug: Tobramycin inhalation solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01641822

2015-000398-11 (EudraCT Number)

GS-US-205-0170

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.

Enrollment: 107 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of CF
• Presence of PA in 2 lower respiratory tract cultures in the 12 months prior to screening
• Forced expiratory volume (FEV)1 ≥ 25 and ≤ 75% predicted
• History of 1 hospitalization or 1 course of IV antibiotics for an acute respiratory exacerbation in the 12 months prior to screening

Exclusion criteria

• Concurrent use of oral, IV or inhaled antibiotics at enrollment
• Concurrent hospitalization at enrollment
• History of local or systemic hypersensitivity to monobactams or aminoglycoside antibiotics or history of aminoglycoside antibiotic associated toxicity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups, including a placebo group

AZLI

Active Comparator group

Description:

Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI for 28 days followed by TIS for 28 days.

Treatment:

Drug: Tobramycin inhalation solution

Drug: AZLI

Placebo

Placebo Comparator group

Description:

Participants will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS for 28 days.

Treatment:

Drug: Tobramycin inhalation solution

Drug: Placebo to match AZLI