AsthmaNCT00214526
Asthma Intervention Research (AIR) Trial
A study testing Bronchial thermoplasty with the Alair System and Conventional therapy with ICS+LABA in people with Asthma, run by Asthmatx, Inc..
Trial summary
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Bronchial thermoplasty with the Alair System and Conventional therapy with ICS+LABA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jul 2006
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory adult; age 18-65 years
- Asthma requiring regular maintenance medication that includes inhaled corticosteroid (at least 200 μg beclomethasone per day or equivalent) AND long acting ß2 agonist (LABA) (at least 100 mg salmeterol per day or equivalent)
- Pre-bronchodilator FEV1 60-85% (patients stabilized on inhaled corticosteroids and long acting β2 agonists)
- PC20 < 8 mg/ml per methacholine inhalation test using standardized methods.
- Demonstration of worsening of asthma following 2-week withdrawal of LABA, as documented by either:
- an increase of at least 0.5 in the Juniper Asthma Control Questionnaire score, relative to the Questionnaire score in the 2 weeks preceding withdrawal of LABA, OR
Show all 10Show fewer
- a decline of at least 5% in the average am Peak Expiratory Flow during the second week of LABA abstinence relative to the average am Peak Expiratory Flow during the week immediately preceding LABA withdrawal
- Non-smoker x 1 year or greater (if former smoker, less than 10 pack years total smoking history)
- Willingness and ability to give written Informed Consent
- Willingness and ability to comply with the study protocol, including requirements for taking and abstaining from medications.
Who cannot join
- Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of the pretreatment evaluation, or during the study period
- Current or recent respiratory tract infection (resolved less than 6 weeks from pretreatment evaluation)
- History of recurrent (³ 3 infections/year) lower respiratory tract infection requiring antibiotics.
- With the exception of the use of a prophylactic bronchodilator for exercise, requirement for more than 4 puffs in a 24-hour period of a short-acting b2-adrenergic agonist such as albuterol or salbutamol 100 mg/puff or equivalent within the seven days immediately prior to commencement of Enrollment Testing, Part I.
- Unstable asthma as defined by the need for an extra visit to a healthcare provider, increase in or introduction of new maintenance or symptom relieving medications (including new requirement for IV or nebulized medications) within 6 weeks of enrollment
- Use of an internal or external pacemaker or internal cardiac defibrillator
Show all 25Show fewer
- Significant co-morbid illness such as cancer, renal failure, liver disease or cerebral vascular disease
- POST-bronchodilator FEV1 of less than 65%.
- Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
- Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
- Use of a systemic b-adrenergic blocking agent
- Pregnancy
- Nursing mother
- History of epilepsy
- Cardiovascular disease, including bradycardia, angina, cardiac dysrhythmia, conduction defect or cardiac myopathy
- Myocardial infarction or stroke within 6 months of the pretreatment evaluation
- Any active disease left untreated,
- Bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR > 1.5)
- Use of anticoagulants
- Insulin-dependent diabetes
- Psychiatric disorder which in the judgement of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up
- Presence of segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray
- Interstitial lung disease
- Uncontrolled hypertension (>200 mmHg systolic or >100mmHg diastolic pressure)
- Known aortic aneurysm
About this study
Official title: Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Read the detailed description
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil).
Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.
- Conditions
- Asthma
- Being tested
- Bronchial thermoplasty with the Alair System, Conventional therapy with ICS+LABA
- Keywords
- Asthma, Bronchial Thermoplasty, Airway Hyperresponsiveness
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchial thermoplasty with the Alair SystemProcedure or surgery
Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
Conventional therapy with ICS+LABADrug
Conventional therapy with ICS+LABA.
| Study group | Role | What they receive |
|---|---|---|
| Alair Group | Experimental | Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. Receives: Procedure: Bronchial thermoplasty with the Alair System |
| Control Group | Active comparator | Conventional therapy with ICS+LABA. Receives: Drug: Conventional therapy with ICS+LABA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.
Measured: Baseline, 12 Months
Secondary outcomes (9)
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).
Measured: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in post-bronchodilator forced expiratory volume in 1 second (FEV1) (percent predicted).
Measured: Baseline, 12 Months
Methacholine PC20 (Change From Baseline)
Change from Baseline at 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in "PC20" - provocative concentration of Provocholine (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from baseline. The patient inhales an aerosol of one or more concentrations of methacholine. The lower the concentration of methacholine that provokes a 20% (or greater) fall in FEV1, the more "responsive" or "hyperresponsive" the airways are. Conversely, a rise in methacholine PC20 indicates airways that have become less reactive.
Measured: Baseline, 12 Months
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in morning and evening Peak Expiratory Flow (PEF). The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Measured: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Asthma Control Questionnaire (ACQ) Score. The ACQ is a self-administered patient questionnaire that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (best) to 6 (worst) and averaged, resulting in a total score from 0 to 6. A decrease in the ACQ score indicates better asthma control.
Measured: Baseline, 12 Months
Use of Rescue Medications (Change From Baseline)
Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in use of rescue medications (short acting bronchodilators) measured in puffs per week. Subjects recorded their use of rescue medication for asthma symptoms in their Daily Diary throughout the study.
Measured: Baseline, 12 Months
Use of Maintenance Medications (Change From Baseline)
Change from Baseline at 12-Months (OFF-LABA) Follow-up Visit in use of maintenance medications (inhaled corticosteroids and/or long-acting beta-agonists).
Measured: Baseline, 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in AQLQ score. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). The AQLQ score is the mean of the scores from the 32 individual questions. An increase in the AQLQ score indicates a better quality of life. A within-subject change in score of 0.5 represents the minimal important difference (MID).
Measured: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Change from Baseline at 12-Weeks (ON-LABA) and 12-Weeks, 6-Months, and 12-Months (OFF-LABA) Follow-up Visits in Total Symptom Score. Total Symptom Score comprises the sum of six asthma symptom measurements. Each symptom is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionJul 2006
- Study completionJul 2006
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 AsthmaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asthmatx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Narinder S Shargill, PhD, Study director, Asthmatx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214526
- Sponsor's protocol ID
- Protocol #0602-20
- Status last verified
- Aug 2015
- First submitted
- 15 Sep 2005
- Last updated
- 28 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707.
PubMed 17392302
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
- ClinicalTrials.gov ID
- NCT00214526
- Acronym / sponsor ID
- Protocol #0602-20
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Thermoplasty, Airway Hyperresponsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Asthmatx, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 18 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Detailed description
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil).
Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alair Group | Experimental | Procedure: Bronchial thermoplasty with the Alair SystemConventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. |
| Control Group | Active comparator | Drug: Conventional therapy with ICS+LABAConventional therapy with ICS+LABA. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ambulatory adult; age 18-65 years
- Asthma requiring regular maintenance medication that includes inhaled corticosteroid (at least 200 μg beclomethasone per day or equivalent) AND long acting ß2 agonist (LABA) (at least 100 mg salmeterol per day or equivalent)
- Pre-bronchodilator FEV1 60-85% (patients stabilized on inhaled corticosteroids and long acting β2 agonists)
- PC20 < 8 mg/ml per methacholine inhalation test using standardized methods.
- Demonstration of worsening of asthma following 2-week withdrawal of LABA, as documented by either:
Key exclusion criteria (25 listed)
- Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of the pretreatment evaluation, or during the study period
- Current or recent respiratory tract infection (resolved less than 6 weeks from pretreatment evaluation)
- History of recurrent (³ 3 infections/year) lower respiratory tract infection requiring antibiotics.
- With the exception of the use of a prophylactic bronchodilator for exercise, requirement for more than 4 puffs in a 24-hour period of a short-acting b2-adrenergic agonist such as albuterol or salbutamol 100 mg/puff or equivalent within the seven days immediately prior to commencement of Enrollment Testing, Part I.
- Unstable asthma as defined by the need for an extra visit to a healthcare provider, increase in or introduction of new maintenance or symptom relieving medications (including new requirement for IV or nebulized medications) within 6 weeks of enrollment
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 |
|---|---|---|
| Bronchial thermoplasty with the Alair SystemConventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. | Procedure or surgery | Alair Group |
| Conventional therapy with ICS+LABAConventional therapy with ICS+LABA. | Drug | Control Group |
Primary outcome
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
Time frame: Baseline, 12 Months
Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.
9 secondary outcomes
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Time frame: Baseline, 12 Months
Methacholine PC20 (Change From Baseline)
Time frame: Baseline, 12 Months
Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
Time frame: Baseline, 12 Months
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Use of Rescue Medications (Change From Baseline)
Time frame: Baseline, 12 Months
Use of Maintenance Medications (Change From Baseline)
Time frame: Baseline, 12 Months
Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Time frame: Baseline, 12 Months
Total Symptom Score (Change From Baseline)
Time frame: Baseline, 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17392302Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707.
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Asthma
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.
Narinder S Shargill, PhD study director
Asthmatx, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchial thermoplasty with the Alair System and Conventional therapy with ICS+LABA in people with Asthma, run by Asthmatx, Inc..
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 10 inclusion and 25 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 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2010). 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?
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) (time frame: Baseline, 12 Months). 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 NCT00214526, 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 28 Aug 2015.