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AZLI three times daily · 1 trial · 3 indications
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for children and adults with CF. The CFQ-R contains both general and CF-specific scales. The CFQ-R was administered at Days 0, 14, 28, and 42. The endpoint was change in respiratory symptoms (e.g., coughing, congestion, wheezing) from Day 0 (baseline), assessed with the CFQ-R RSS (score range: 0-100; higher scores indicating fewer symptoms, higher health-related quality of life, or better functioning). Baseline CFQ-R RSS and age group (\<18 vs. \>=18 years) were included as covariates in the analysis.
| Arm | Type | Description |
|---|---|---|
| Placebo three times daily (TID) | PLACEBO_COMPARATOR | - |
| AZLI 75 mg three times daily (TID) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AZLI 75 mg three times daily (TID) | DRUG | - |
| Placebo three times daily (TID) | DRUG | - |
Inclusion Criteria: * Participants ≥ 6 years of age * Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: * Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test * Two well ch...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
AZLI three times daily is an investigational inhaled formulation of aztreonam, a small molecule antibiotic, given as 75 mg three times daily to treat lung infection caused by Pseudomonas aeruginosa in people with cystic fibrosis. It is being developed by Gilead Sciences, Inc. (ticker GILD) and has been studied in a Phase 3 trial.
AZLI three times daily is used for cystic fibrosis with mild lung disease and Pseudomonas aeruginosa lung infection. The Phase 3 study enrolled patients with cystic fibrosis, lung infection, and P. aeruginosa. It is an inhaled antibiotic approach intended to deliver the drug directly to the airways in this patient population.
AZLI three times daily is developed by Gilead Sciences, Inc., which trades under the ticker GILD. Gilead is the sponsor of the Phase 3 clinical program evaluating this inhaled aztreonam formulation in cystic fibrosis patients with Pseudomonas aeruginosa lung infection.
AZLI three times daily is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and is not described as approved. The completed study was randomized, double blind, and placebo controlled, enrolling 160 patients.
AZLI three times daily has been studied in one completed Phase 3 trial, NCT00712166, titled a safety and efficacy study of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung disease, and P. aeruginosa. It enrolled 160 participants across the United States, Australia, and Canada, with patients aged 6 years and older.