BronchiectasisPhase 3AIR-BX2NCT01314716
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
A Phase 3 study testing AZLI in people with Bronchiectasis, run by Gilead Sciences at 85 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- AZLI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 85 sitesin 10 countries
- Study dates
- Apr 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
85 sites in 10 countries.
85 sites in 10 countries
United States33 sites
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
Loess Hills Clinical Research
Council Bluffs, Iowa, 51503
Southeastern Lung Care PC
Decatur, Georgia, 30033
Clinical Trials Connection
Flagstaff, Arizona, 86001
Florence Research Associates
Florence, Alabama, 35630
University of Florida
Jacksonville, Florida, 32209
Jamaica Hospital Medical Center
Jamaica, New York, 11418
Kentuckiana Pulmonary Associates
Louisville, Kentucky, 40202
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
University of Miami Miller School of Medicine
Miami, Florida, 33136
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, 53226
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Columbia University, NY Presbyterian Hospital
New York, New York, 10032
Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.
Orange, California, 92780
Central Florida Pulmonary Group
Orlando, Florida, 32803
Phoenix Medical Group
Peoria, Arizona, 85381
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Pulmonary Associates
Phoenix, Arizona, 85006
The Oregon Clinic P.C./ Pulmonary Division
Portland, Oregon, 97220
Pulmonary & Critical Care Associates of Baltimore
Rosedale, Maryland, 21237
University of Utah
Salt Lake City, Utah, 84132
UC San Diego Medical Center
San Diego, California, 92103
California Pacific Medical Center
San Francisco, California, 94115
Sarasota Memorial Hospital - Clinical Research Center
Sarasota, Florida, 34239
AZ Pulmonary Specialists, LTD
Scottsdale, Arizona, 85258
Pasadena Center for Medical Research
St. Petersburg, Florida, 33707
Pulmonary & Allergy Associates, P.A.
Summit, New Jersey, 07901
Pulmonary Consultants, PLLC
Tacoma, Washington, 98405
Tampa General Hospital - New Lung Associates
Tampa, Florida, 33606
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Florida Premier Research Institute
Winter Park, Florida, 32789
Germany10 sites
Charite Campus Virchow-Klinikum
Berlin, 12200
Research Center for Medical Studies (RCMS)
Berlin-Charlottenburg (Westend), 14052
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
University Hospital Giessen
Giessen, 35392
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum des Saarlandes
Homburg, 66421
Universitätsklinikum Jena Clinic for Internal Medicine II
Jena, 07747
Univ.-Klinikum Leipzig, Innere Med.
Leipzig, 04103
POIS Leipzig GbR
Leipzig, 04357
Klinikum Innenstadt der LMU Munchen
Munich, 80336
Australia9 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Concord Hospital
Concord, New South Wales, 2139
St Vincent's Hospital
Darlinghurst, New South Wales, 2010
Repatriation General Hospital
Daw Park, South Australia, 5041
St George Hospital
Kogarah, New South Wales, 2217
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, New South Wales, 6000
Burnside War Memorial Hospital Pharmacy
Toorak Gardens, South Australia, 5065
Westmead Hospital
Westmead, New South Wales, 2145
United Kingdom7 sites
Papworth Hospital NHS Trust
Cambridgeshire, CB23 3RE
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Royal Devon and Exeter Hospital, NHS Foundation Trust
Exeter, EX5 5AN
Sir William Leech Centre for Lung Research, Freeman Hospital
Newcastle upon Tyne, NE7 7DN
GBS RE Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, 532 1DA
Torbay District General Hospital
Torquay, Devon, TQ2 7AA
Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, WV10 0QP
France6 sites
CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP
Gap, PACA, 05007 Cedex
Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord
Marseille, 13015
CHU de Montpellier-Hopital Arnaud de Villeneuve
Montpellier, 34295
Hôpital Pasteur, CHU de Nice
Nice, 6002
Hopital Haut-Leveque
Pessac, 33604
CHU Toulouse - Hôpital Larrey
Toulouse, 31054 cedex 9
Italy6 sites
S.Anna Hospital, University of Ferrara
Ferrara, 44121
UO Broncopneumologia IRCCS Fondazione Cà Granda Milano
Milan, 20122
University of Modena and Reggio Emilia
Modena, 41100
Azienda Universitaria Federico II
Naples, 80131
Università di Pisa - Ospedale Cisanello
Pisa, 56124
Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica
Verona, 37124
Spain6 sites
Hospital Vall d´Hebrón
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Josep Trueta
Girona, 17007
Hospital Universitario La Paz
Madrid, 28046
Hospital La Fe
Valencia, 46009
Belgium3 sites
CUB Hôpital Erasme
Brussels, 1070
Universitair Ziekenhuis Antwerpen
Edegem, 2650
KUL UZ Gasthuisberg
Leuven, 3000
Canada3 sites
Kelowna Respiratory Research and Allergy Clinic
Kelowna, British Columbia, V1W 1V3
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Netherlands2 sites
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
Erasmus MC
Rotterdam, 3015GD
About this study
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)
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
- Being tested
- AZLI, Placebo
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZLIDrug
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
PlaceboDrug
Placebo to match AZLI administered via nebulizer three times daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: AZLI; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 28
Secondary outcomes (2)
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.
Measured: Baseline to Day 84
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
Measured: Baseline to Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne O'Donnell, MD, Principal investigator, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314716
- Sponsor's protocol ID
- GS-US-219-0104
- Acronym
- AIR-BX2
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2011
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25154045
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01314716
- Acronym / sponsor ID
- AIR-BX2 / GS-US-219-0104
- Conditions
- Bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Posted 16 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZLI-AZLI | Experimental | Drug: AZLIParticipants 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. |
| Placebo-AZLI | Placebo comparator | Drug: AZLI, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZLIAZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily | Drug | AZLI-AZLI, Placebo-AZLI |
| PlaceboPlacebo to match AZLI administered via nebulizer three times daily | Drug | Placebo-AZLI |
Primary outcome
Change in QOL-B Respiratory Symptoms Score at Day 28
Time frame: Baseline to 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.
2 secondary outcomes
Change in QOL-B Respiratory Symptoms Score at Day 84
Time frame: Baseline to Day 84
Time to Protocol-Defined Exacerbation (PDE)
Time frame: Baseline to Day 112
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25154045Barker 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.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne O'Donnell, MD principal investigator
Georgetown University Hospital
85 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZLI in people with Bronchiectasis, run by Gilead Sciences at 85 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Germany, Australia, United Kingdom, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QOL-B Respiratory Symptoms Score at Day 28 (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.