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

NCT01314716 | Completed Phase 3 Results DMC

• 1 other identifier: GS-US-219-0104
• Study Type: interventional
• Target: 274
• Locations: 10 countries
• Sites: 85

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.

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in QOL-B Respiratory Symptoms Score at Day 84

  Baseline to Day 84

• Time to Protocol-Defined Exacerbation (PDE)

  Baseline to Day 112

Study Arms (2)

AZLI-AZLI

EXPERIMENTAL

Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

Drug: AZLI

Placebo-AZLI

PLACEBO COMPARATOR

Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

Drug: AZLI; Drug: Placebo

Interventions

AZLI DRUG

AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

AZLI-AZLI; Placebo-AZLI

Placebo DRUG

Placebo to match AZLI administered via nebulizer three times daily

Placebo-AZLI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (85)

Florence Research Associates

Florence, Alabama, 35630, United States

Location

Clinical Trials Connection

Flagstaff, Arizona, 86001, United States

Location

Phoenix Medical Group

Peoria, Arizona, 85381, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

AZ Pulmonary Specialists, LTD

Scottsdale, Arizona, 85258, United States

Location

Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

Orange, California, 92780, United States

Location

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Hospital - Clinical Research Center

Sarasota, Florida, 34239, United States

Location

Pasadena Center for Medical Research

St. Petersburg, Florida, 33707, United States

Location

Tampa General Hospital - New Lung Associates

Tampa, Florida, 33606, United States

Location

Florida Premier Research Institute

Winter Park, Florida, 32789, United States

Location

Southeastern Lung Care PC

Decatur, Georgia, 30033, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Loess Hills Clinical Research

Council Bluffs, Iowa, 51503, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

Pulmonary & Critical Care Associates of Baltimore

Rosedale, Maryland, 21237, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Pulmonary & Allergy Associates, P.A.

Summit, New Jersey, 07901, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

Columbia University, NY Presbyterian Hospital

New York, New York, 10032, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Oregon Clinic P.C./ Pulmonary Division

Portland, Oregon, 97220, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Pulmonary Consultants, PLLC

Tacoma, Washington, 98405, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Concord Hospital

Concord, New South Wales, 2139, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Royal Perth Hospital

Perth, New South Wales, 6000, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Repatriation General Hospital

Daw Park, South Australia, 5041, Australia

Location

Burnside War Memorial Hospital Pharmacy

Toorak Gardens, South Australia, 5065, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

CUB Hôpital Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

KUL UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Kelowna Respiratory Research and Allergy Clinic

Kelowna, British Columbia, V1W 1V3, Canada

Location

The Lung Centre at Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP

Gap, PACA, 05007 Cedex, France

Location

Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord

Marseille, 13015, France

Location

CHU de Montpellier-Hopital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Hôpital Pasteur, CHU de Nice

Nice, 6002, France

Location

Hopital Haut-Leveque

Pessac, 33604, France

Location

CHU Toulouse - Hôpital Larrey

Toulouse, 31054 cedex 9, France

Location

Charite Campus Virchow-Klinikum

Berlin, 12200, Germany

Location

Research Center for Medical Studies (RCMS)

Berlin-Charlottenburg (Westend), 14052, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

University Hospital Giessen

Giessen, 35392, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitätsklinikum Jena Clinic for Internal Medicine II

Jena, 07747, Germany

Location

Univ.-Klinikum Leipzig, Innere Med.

Leipzig, 04103, Germany

Location

POIS Leipzig GbR

Leipzig, 04357, Germany

Location

Klinikum Innenstadt der LMU Munchen

Munich, 80336, Germany

Location

S.Anna Hospital, University of Ferrara

Ferrara, 44121, Italy

Location

UO Broncopneumologia IRCCS Fondazione Cà Granda Milano

Milan, 20122, Italy

Location

University of Modena and Reggio Emilia

Modena, 41100, Italy

Location

Azienda Universitaria Federico II

Naples, 80131, Italy

Location

Università di Pisa - Ospedale Cisanello

Pisa, 56124, Italy

Location

Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica

Verona, 37124, Italy

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Erasmus MC

Rotterdam, 3015GD, Netherlands

Location

Hospital Vall d´Hebrón

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital La Fe

Valencia, 46009, Spain

Location

Papworth Hospital NHS Trust

Cambridgeshire, CB23 3RE, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Royal Devon and Exeter Hospital, NHS Foundation Trust

Exeter, EX5 5AN, United Kingdom

Location

Sir William Leech Centre for Lung Research, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

GBS RE Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, 532 1DA, United Kingdom

Location

Torbay District General Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25154045 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Anne O'Donnell, MD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 14, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 16, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-03

Locations

BE (3); GB (7); US (33); CA (3); FR (6); DE (10); IT (6); AU (9); ES (6); NL (2)