Clinical trial NCT01314716: Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Official title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiectasis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.


Eligibility criteria: Inclusion Criteria:

* Male/Female 18 years or older with non-CF bronchiectasis
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements

Exclusion Criteria:

* History of CF
* Hospitalized within 14 days prior to joining the study
* Previous exposure to AZLI
* Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
* Must have met liver and kidney function requirements
* Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
* Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
* Other serious medical conditions.

Primary outcomes:
measure: Change in QOL-B Respiratory Symptoms Score at Day 28
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change in QOL-B Respiratory Symptoms Score at Day 84
timeFrame: Baseline to Day 84
measure: Time to Protocol-Defined Exacerbation (PDE)
timeFrame: Baseline to Day 112
Other outcomes:
Locations:
city: Florence
country: United States
facility: Florence Research Associates
state: Alabama
city: Flagstaff
country: United States
facility: Clinical Trials Connection
state: Arizona
city: Peoria
country: United States
facility: Phoenix Medical Group
state: Arizona
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Scottsdale
country: United States
facility: AZ Pulmonary Specialists, LTD
state: Arizona
city: Orange
country: United States
facility: Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital - Clinical Research Center
state: Florida
city: St. Petersburg
country: United States
facility: Pasadena Center for Medical Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital - New Lung Associates
state: Florida
city: Winter Park
country: United States
facility: Florida Premier Research Institute
state: Florida
city: Decatur
country: United States
facility: Southeastern Lung Care PC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Council Bluffs
country: United States
facility: Loess Hills Clinical Research
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Rosedale
country: United States
facility: Pulmonary & Critical Care Associates of Baltimore
state: Maryland
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Summit
country: United States
facility: Pulmonary & Allergy Associates, P.A.
state: New Jersey
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New York
country: United States
facility: Columbia University, NY Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: The Oregon Clinic P.C./ Pulmonary Division
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center
state: Pennsylvania
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Tacoma
country: United States
facility: Pulmonary Consultants, PLLC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Froedtert Hospital
state: Wisconsin
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Perth
country: Australia
facility: Royal Perth Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Daw Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: Toorak Gardens
country: Australia
facility: Burnside War Memorial Hospital Pharmacy
state: South Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Brussels
country: Belgium
facility: CUB Hôpital Erasme
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: KUL UZ Gasthuisberg
city: Kelowna
country: Canada
facility: Kelowna Respiratory Research and Allergy Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: The Lung Centre at Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Gap, PACA
country: France
facility: CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP
city: Marseille
country: France
facility: Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord
city: Montpellier Cedex 05
country: France
facility: CHU de Montpellier-Hopital Arnaud de Villeneuve
city: Nice
country: France
facility: Hôpital Pasteur, CHU de Nice
city: Pessac
country: France
facility: Hopital Haut-Leveque
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Larrey
city: Berlin-Charlottenburg (Westend)
country: Germany
facility: Research Center for Medical Studies (RCMS)
city: Berlin
country: Germany
facility: Charite Campus Virchow-Klinikum
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Giessen
country: Germany
facility: University Hospital Giessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena Clinic for Internal Medicine II
city: Leipzig
country: Germany
facility: Univ.-Klinikum Leipzig, Innere Med.
city: Leipzig
country: Germany
facility: POIS Leipzig GbR
city: Munich
country: Germany
facility: Klinikum Innenstadt der LMU Munchen
city: Ferrara
country: Italy
facility: S.Anna Hospital, University of Ferrara
city: Milan
country: Italy
facility: UO Broncopneumologia IRCCS Fondazione Cà Granda Milano
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
city: Naples
country: Italy
facility: Azienda Universitaria Federico II
city: Pisa
country: Italy
facility: Università di Pisa - Ospedale Cisanello
city: Verona
country: Italy
facility: Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital La Fe
city: Cambridgeshire
country: United Kingdom
facility: Papworth Hospital NHS Trust
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital, NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Sir William Leech Centre for Lung Research, Freeman Hospital
city: Sheffield
country: United Kingdom
facility: GBS RE Sheffield Teaching Hospitals NHS Foundation Trust
city: Torquay, Devon
country: United Kingdom
facility: Torbay District General Hospital
city: Wolverhampton
country: United Kingdom
facility: Royal Wolverhampton Hospitals NHS Trust
Study officials:
affiliation: Georgetown University Hospital
name: Anne O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.