BronchiectasisPhase 3AIR-BX1NCT01313624
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 60 sites in 3 countries.
Trial summary
The AIR-BX1 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
- 266 participants
- Where
- 60 sitesin 3 countries
- Study dates
- Apr 2011to Jun 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
60 sites in 3 countries.
60 sites in 3 countries
United States36 sites
Albany Medical Center
Albany, New York, 12208
Atlanta Pulmonary Group
Atlanta, Georgia, 30342
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21204
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Pulmonary and Critical Care
Charlottesville, Virginia, 22908
Cardio Pulmonary Research at St. Luke's Hospital
Chesterfield, Missouri, 63017
University of Cincinnati / UC Health
Cincinnati, Ohio, 45267
Bay Area Chest Physicians
Clearwater, Florida, 33756
National Jewish Health
Denver, Colorado, 80202
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
Falls Church, Virginia, 22042
University of Connecticut Health Center
Farmington, Connecticut, 06030
University of Florida
Gainesville, Florida, 32610
Jamaica Hospital Medical Center
Jamaica, New York, 11418
Pulmonary Disease Specialists (PDS) Research
Kissimmee, Florida, 34741
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Metroplex Pulmonary and Sleep Center
McKinney, Texas, 75069
University of Miami - Miller School of Medicine
Miami, Florida, 33136
Winthrop University Hospital - Clinical Trials Center
Mineola, New York, 11501
St. Luke's Roosevelt Hospital
New York, New York, 10019
Central Florida Pulmonary Group
Orlando, Florida, 32803
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
Philadelphia, Pennsylvania, 19104
Asthma Allergy & Pulmonary Associates
Philadelphia, Pennsylvania, 19107
Pulmonary Associates
Phoenix, Arizona, 85006
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, 85012
St. Joseph's Hospital and Medical Center Heart and Lung Institute
Phoenix, Arizona, 85013
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
Sacramento, California, 95817
Alamo Clinical Research Associates
San Antonio, Texas, 78212
Arizona Pulmonary Specialists
Scottsdale, Arizona, 85258
Swedish Medical Center/Minor James Clinic
Seattle, Washington, 98104
Multicare Pulmonary Specialist
Tacoma, Washington, 98405
University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
Landon Pediatric Foundation
Ventura, California, 93003
Cleveland Clinic Florida
Weston, Florida, 33331
Australia15 sites
Royla Adelaide Hospital
Adelaide, South Australia, 5000
Mater Adult Hospital
Brisbane, Queensland, 4101
The Prince Charles Hospital
Chermside, Queensland, 4032
Monash Medical Centre
Clayton, Victoria, 3168
Concord Hospital
Concord, New South Wales, 2139
St. Vincent's Hospital
Darlinghurst, New South Wales, 2010
Repatriation General Hospital
Daws Park, South Australia, 5041
Peninsula Health
Frankston, Victoria, 3199
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037
St. George Hospital
Kogarah, New South Wales, 2217
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Royal Perth Hospital
Perth, New South Wales, 6000
Respiratory Clinical Trials
Toorak Gardens, South Australia, 5065
Westmead Hospital
Westmead, New South Wales, 2145
Alfred Hospital
Westmead, Victoria, 3194
Canada9 sites
University of Calgary
Calgary, Alberta, T2N 4N1
University of Alberta
Edmonton, Alberta, T6G 2C8
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, V1W 1V3
Kingston General Hospital / Queen's University
Kingston, Ontario, K7L 2V6
Centre Hospitalier de L'Université de Montréal Hotel Dieu
Montreal, Quebec, H2W 1T8
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Lung Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St. Paul's Hospital Pacific Lung Research
Vancouver, British Columbia, V6Z 1Y6
Dr. Anil Dhar Private Practice
Windsor, Ontario, N8X 5A6
About this study
Official title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection
The AIR-BX1 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 completionMar 2013
- Study completionJun 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
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Barker, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313624
- Sponsor's protocol ID
- GS-US-219-0101
- Acronym
- AIR-BX1
- Status last verified
- Mar 2014
- First submitted
- 10 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 in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection
- ClinicalTrials.gov ID
- NCT01313624
- Acronym / sponsor ID
- AIR-BX1 / GS-US-219-0101
- Conditions
- Bronchiectasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 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-BX1 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.
Related trials for Bronchiectasis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
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.
Alan Barker, MD principal investigator
Oregon Health and Science University
60 sites in 3 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 60 sites in 3 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 60 sites in United States, Australia, Canada. 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 NCT01313624, 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.