AZLI: Clinical Trials

8 completed, 1 terminated. 7 Phase 3, 1 Phase 2, 1 Phase 4.

By phase and status

Phase	Trials	Status
Phase 3	7	Completed 6, Terminated 1
Phase 2	1	Completed 1
Phase 4	1	Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria AZLI, Placebo - Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis	Phase 3	Terminated	Gilead Sciences	149	2017-11-28	2022-06-14
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis Aztreonam, Standard Care - Cystic Fibrosis, Infection	Phase 4	Completed	Liverpool Heart and Chest Hospital NHS Foundation Trust	16	2017-01-01	2019-10-07
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, Placebo to match AZLI, Tobramycin inhalation solution - Cystic Fibrosis	Phase 3	Completed	Gilead Sciences	107	2012-12-01	2016-05-09
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways AZLI - Cystic Fibrosis, Pseudomonas Aeruginosa	Phase 3	Completed	Gilead Sciences	61	2011-12-01	2014-05-29
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis AZLI, Placebo - Bronchiectasis	Phase 3	Completed	Gilead Sciences	266	2011-04-01	2014-04-16
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis AZLI, Placebo - Bronchiectasis	Phase 3	Completed	Gilead Sciences	274	2011-04-01	2014-04-16
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection AZLI, Placebo - Cystic Fibrosis, Burkholderia Infections	Phase 3	Completed	Gilead Sciences	102	2010-02-01	2014-03-11
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis AZLI - Bronchiectasis	Phase 2	Completed	Gilead Sciences	89	2008-12-01	2014-03-20
Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa Aztreonam for Inhalation Solution (AZLI), Tobramycin Inhalation Solution (TIS) - Cystic Fibrosis	Phase 3	Completed	Gilead Sciences	274	2008-08-01	2011-07-04

Conditions studied

Cystic Fibrosis (6)  ·  Bronchiectasis (3)  ·  Pseudomonas Infections (3)  ·  Burkholderia Infections (1)  ·  Infections (1)

Sponsors

Gilead Sciences (8)  ·  Liverpool Heart and Chest Hospital NHS Foundation Trust (1)

Countries

United States (8)  ·  France (4)  ·  Germany (4)  ·  Italy (4)  ·  Spain (4)  ·  United Kingdom (4)  ·  Belgium (3)  ·  Canada (3)  ·  Netherlands (3)  ·  Australia (2)  ·  Austria (2)  ·  Denmark (2)  ·  Greece (1)  ·  Ireland (1)  ·  Israel (1)

Top investigators

Mark Bresnik, MD (3)  ·  Alan Barker, MD (1)  ·  Anne O'Donnell, MD (1)  ·  Freddy Frost, BMBS BMedSci (1)  ·  Mark Bresnik, M.D. (1)  ·  Steve Lamola, MD (1)

Results publications

PMID 25154045, PMID 22985692, PMID 24626872, PMID 27233377, PMID 33358119, PMID 37455237

NIH funding

2015 (1), 2016 (1)