Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Bronchiectasis Clinical Trial

— AIR-BX2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314716
• Other study ID #: GS-US-219-0104
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2011
• Last updated: March 7, 2014
• Start date: April 2011
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySpain: Spanish Agency of MedicinesNetherlands: Medicines Evaluation Board (MEB)Italy: The Italian Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
• Placebo
Placebo to match AZLI administered via nebulizer three times daily

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Concord Hospital	Concord	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Repatriation General Hospital	Daw Park	South Australia
Australia	St George Hospital	Kogarah	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	New South Wales
Australia	Burnside War Memorial Hospital Pharmacy	Toorak Gardens	South Australia
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	CUB Hôpital Erasme	Brussels
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	KUL UZ Gasthuisberg	Leuven
Canada	Kelowna Respiratory Research and Allergy Clinic	Kelowna	British Columbia
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	The Lung Centre at Vancouver General Hospital	Vancouver	British Columbia
France	CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP	Gap, PACA
France	Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord	Marseille
France	CHU de Montpellier-Hopital Arnaud de Villeneuve	Montpellier Cedex 05
France	Hôpital Pasteur, CHU de Nice	Nice
France	Hopital Haut-Leveque	Pessac
France	CHU Toulouse - Hôpital Larrey	Toulouse
Germany	Charite Campus Virchow-Klinikum	Berlin
Germany	Research Center for Medical Studies (RCMS)	Berlin-Charlottenburg (Westend)
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	University Hospital Giessen	Giessen
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Jena Clinic for Internal Medicine II	Jena
Germany	POIS Leipzig GbR	Leipzig
Germany	Univ.-Klinikum Leipzig, Innere Med.	Leipzig
Germany	Klinikum Innenstadt der LMU Munchen	Munich
Italy	S.Anna Hospital, University of Ferrara	Ferrara
Italy	UO Broncopneumologia IRCCS Fondazione Cà Granda Milano	Milan
Italy	University of Modena and Reggio Emilia	Modena
Italy	Azienda Universitaria Federico II	Naples
Italy	Università di Pisa - Ospedale Cisanello	Pisa
Italy	Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica	Verona
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Erasmus MC	Rotterdam
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital Universitario de Bellvitge	Barcelona
Spain	Hospital Vall d´Hebrón	Barcelona
Spain	Hospital Josep Trueta	Girona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital La Fe	Valencia
United Kingdom	Papworth Hospital NHS Trust	Cambridgeshire
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Royal Devon and Exeter Hospital, NHS Foundation Trust	Exeter
United Kingdom	Sir William Leech Centre for Lung Research, Freeman Hospital	Newcastle upon Tyne
United Kingdom	GBS RE Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Torbay District General Hospital	Torquay, Devon
United Kingdom	Royal Wolverhampton Hospitals NHS Trust	Wolverhampton
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Loess Hills Clinical Research	Council Bluffs	Iowa
United States	Southeastern Lung Care PC	Decatur	Georgia
United States	Clinical Trials Connection	Flagstaff	Arizona
United States	Florence Research Associates	Florence	Alabama
United States	University of Florida	Jacksonville	Florida
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Medical College of Wisconsin Froedtert Hospital	Milwaukee	Wisconsin
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University, NY Presbyterian Hospital	New York	New York
United States	Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.	Orange	California
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	Phoenix Medical Group	Peoria	Arizona
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona
United States	The Oregon Clinic P.C./ Pulmonary Division	Portland	Oregon
United States	Pulmonary & Critical Care Associates of Baltimore	Rosedale	Maryland
United States	University of Utah	Salt Lake City	Utah
United States	UC San Diego Medical Center	San Diego	California
United States	California Pacific Medical Center	San Francisco	California
United States	Sarasota Memorial Hospital - Clinical Research Center	Sarasota	Florida
United States	AZ Pulmonary Specialists, LTD	Scottsdale	Arizona
United States	Pasadena Center for Medical Research	St. Petersburg	Florida
United States	Pulmonary & Allergy Associates, P.A.	Summit	New Jersey
United States	Pulmonary Consultants, PLLC	Tacoma	Washington
United States	Tampa General Hospital - New Lung Associates	Tampa	Florida
United States	University of Texas Health Science Center at Tyler	Tyler	Texas
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Florida Premier Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QOL-B Respiratory Symptoms Score at Day 28	The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.	Baseline to Day 28	No
Secondary	Change in QOL-B Respiratory Symptoms Score at Day 84	The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.	Baseline to Day 84	No
Secondary	Time to Protocol-Defined Exacerbation (PDE)	Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.; Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough; Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis	Baseline to Day 112	No