CompletedNCT00214526Updated Aug 28, 2015Results posted

Asthma Intervention Research (AIR) Trial

An interventional study of Bronchial thermoplasty with the Alair System and Conventional therapy with ICS+LABA in Asthma, sponsored by Asthmatx, Inc.. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-08-28.

Sponsored by Asthmatx, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 112
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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. 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 studied

Asthma

Browse trials for

Asthma 3,921

Keywords

Asthma
Bronchial Thermoplasty
Airway Hyperresponsiveness

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 112 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

This is the only study on the registry with Asthmatx, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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
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.

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 112 participants (actual)

Study arms

Experimental
Alair Group
Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
Procedure: Bronchial thermoplasty with the Alair System
Active comparator
Control Group
Conventional therapy with ICS+LABA.
Drug: Conventional therapy with ICS+LABA

Interventions

ProcedureBronchial thermoplasty with the Alair System
Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
DrugConventional therapy with ICS+LABA
Conventional therapy with ICS+LABA.

What researchers measure

Primary outcomes

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.
Time frame: Baseline, 12 Months

Secondary outcomes

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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 12 Months

Results

Posted Oct 18, 2010

Participant flow

Randomized

Participant flow — Randomized
Milestone	Alair Group	Control Group
Started	56	56
Completed	55	54
Not completed	1	2

Treatment Period

Participant flow — Treatment Period
Milestone	Alair Group	Control Group
Started	55	54
Completed	53	49
Not completed	2	5

Post-Treatment Period

Participant flow — Post-Treatment Period
Milestone	Alair Group	Control Group
Started	53	49
Completed	52	49
Not completed	1	0

Outcome measures

PrimaryMild 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.

Time frame:: Baseline, 12 Months
Reported as:: Mean · Exacerbations/Subject/Week

Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
Exacerbations/Subject/Week	Alair Group	Control Group
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)	-0.16 ± 0.37	0.04 ± 0.29

SecondaryPre-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).

Time frame:: Baseline, 12 Months
Reported as:: Mean · Percent Change

Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent Change	Alair Group	Control Group
ON-LABA at 12 Weeks	3.65 ± 17.54	0.32 ± 12.37
OFF-LABA at 12 Weeks	5.28 ± 12.00	4.00 ± 24.22
OFF-LABA at 6 Months	7.29 ± 15.58	5.17 ± 17.67
OFF-LABA at 12 Months	8.33 ± 20.73	3.94 ± 20.49

SecondaryPost-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).

Time frame:: Baseline, 12 Months
Reported as:: Mean · Percent Change

Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Percent Change	Alair Group	Control Group
ON-LABA at 12 Weeks	-0.13 ± 12.03	-0.13 ± 8.63
OFF-LABA at 12 Weeks	0.76 ± 12.65	0.80 ± 16.01
OFF-LABA at 6 Months	0.82 ± 11.67	0.13 ± 11.55
OFF-LABA at 12 Months	0.89 ± 13.91	1.33 ± 13.08

SecondaryMethacholine 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.

Time frame:: Baseline, 12 Months
Reported as:: Geometric mean · mg/mL

Methacholine PC20 (Change From Baseline)
mg/mL	Alair Group	Control Group
OFF-LABA at 12 Weeks	0.64 (0.37 to 1.09)	0.37 (0.24 to 0.58)
OFF-LABA at 6 Months	0.50 (0.30 to 0.85)	0.42 (0.25 to 0.70)
OFF-LABA at 12 Months	0.61 (0.36 to 1.03)	0.50 (0.31 to 0.80)

SecondaryPeak 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.

Time frame:: Baseline, 12 Months
Reported as:: Mean · L/min

Peak Expiratory Flow (Morning and Evening) (Change From Baseline)
L/min	Alair Group	Control Group
Morning PEF: ON-LABA at 12 Weeks	27.96 ± 48.98	1.37 ± 32.26
Morning PEF: OFF-LABA at 12 Weeks	42.59 ± 41.77	12.98 ± 37.08
Morning PEF: OFF-LABA at 6 Months	31.49 ± 42.48	7.39 ± 45.03
Morning PEF: OFF-LABA at 12 Months	39.31 ± 48.74	8.52 ± 44.18
Evening PEF: ON-LABA at 12 Weeks	29.85 ± 49.11	0.57 ± 32.51
Evening PEF: OFF-LABA at 12 Weeks	38.23 ± 48.97	12.58 ± 32.69
Evening PEF: OFF-LABA at 6 Months	29.38 ± 46.35	9.53 ± 41.39
Evening PEF: OFF-LABA at 12 Months	37.70 ± 50.53	9.88 ± 40.95

SecondaryAsthma 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.

Time frame:: Baseline, 12 Months
Reported as:: Mean · Units on a scale

Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Units on a scale	Alair Group	Control Group
ON-LABA at 12 Weeks	-0.30 ± 0.77	-0.01 ± 0.68
OFF-LABA at 12 Weeks	-1.15 ± 1.01	-0.30 ± 1.02
OFF-LABA at 6 Months	-1.23 ± 0.98	-0.51 ± 0.97
OFF-LABA at 12 Months	-1.18 ± 1.02	-0.47 ± 1.00

SecondaryUse 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.

Time frame:: Baseline, 12 Months
Reported as:: Mean · Puffs/7 Days

Use of Rescue Medications (Change From Baseline)
Puffs/7 Days	Alair Group	Control Group
ON-LABA at 12 Weeks	-3.62 ± 11.97	0.94 ± 12.10
OFF-LABA at 12 Weeks	-9.08 ± 15.59	-2.56 ± 12.75
OFF-LABA at 6 Months	-5.84 ± 15.59	-1.26 ± 14.10
OFF-LABA at 12 Months	-8.93 ± 17.21	-1.17 ± 16.71

SecondaryUse 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).

Time frame:: Baseline, 12 Months
Reported as:: Number · Subjects

Use of Maintenance Medications (Change From Baseline)
Subjects	Alair Group	Control Group
No Change in ICS Dosage	52	52
Increase in ICS Dosage	1	1
Decrease in ICS Dosage	2	1

SecondaryAsthma 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).

Time frame:: Baseline, 12 Months
Reported as:: Mean · Units on a scale

Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Units on a scale	Alair Group	Control Group
ON-LABA at 12 Weeks	0.48 ± 0.94	0.01 ± 0.90
OFF-LABA at 12 Weeks	1.25 ± 1.18	0.29 ± 1.06
OFF-LABA at 6 Months	1.23 ± 1.10	0.54 ± 1.06
OFF-LABA at 12 Months	1.27 ± 1.01	0.58 ± 1.09

SecondaryTotal 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.

Time frame:: Baseline, 12 Months
Reported as:: Mean · Units on a scale

Total Symptom Score (Change From Baseline)
Units on a scale	Alair Group	Control Group
ON-LABA at 12 Weeks	-1.18 ± 2.16	-0.33 ± 1.89
OFF-LABA at 12 Weeks	-1.73 ± 2.13	-0.37 ± 2.24
OFF-LABA at 6 Months	-1.60 ± 2.13	-0.66 ± 2.28
OFF-LABA at 12 Months	-1.91 ± 2.11	-0.65 ± 2.48

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Alair (Treatment Period)	—	4/55 (7.3%)	53/55 (96.4%)
Control (Treatment Period)	—	4/54 (7.4%)	43/54 (79.6%)
Alair (Post-Treatment Period)	—	5/55 (9.1%)	52/55 (94.5%)
Control (Post-Treatment Period)	—	4/54 (7.4%)	46/54 (85.2%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Alair (Treatment Period)	Control (Treatment Period)	Alair (Post-Treatment Period)	Control (Post-Treatment Period)
AsthmaRespiratory, thoracic and mediastinal disorders	3/55	0/54	2/55	1/54
Abdominal Pain UpperGastrointestinal disorders	0/55	1/54	0/55	0/54
Atrial FibrillationCardiac disorders	0/55	0/54	0/55	1/54
Calculus UrinaryRenal and urinary disorders	0/55	0/54	0/55	1/54
Chest PainRespiratory, thoracic and mediastinal disorders	0/55	1/54	0/55	0/54
DyspnoeaRespiratory, thoracic and mediastinal disorders	1/55	1/54	0/55	1/54
GastritisGastrointestinal disorders	0/55	1/54	0/55	0/54
Spinal FractureInjury, poisoning and procedural complications	0/55	1/54	0/55	0/54
Collapse Of Lung (Partial Collapse Of Left Upper Lobe)Respiratory, thoracic and mediastinal disorders	1/55	0/54	0/55	0/54
HeadacheNervous system disorders	0/55	0/54	1/55	0/54

Most frequent other events

Showing 10 of 40

Most frequent other events
Event	Alair (Treatment Period)	Control (Treatment Period)	Alair (Post-Treatment Period)	Control (Post-Treatment Period)
DyspnoeaRespiratory, thoracic and mediastinal disorders	38/55	17/54	26/55	28/54
WheezingRespiratory, thoracic and mediastinal disorders	34/55	7/54	16/55	12/54
CoughRespiratory, thoracic and mediastinal disorders	29/55	10/54	21/55	19/54
Nocturnal DyspnoeaRespiratory, thoracic and mediastinal disorders	22/55	5/54	7/55	5/54
Productive CoughRespiratory, thoracic and mediastinal disorders	20/55	5/54	11/55	11/54
Chest DiscomfortRespiratory, thoracic and mediastinal disorders	16/55	10/54	11/55	7/54
HeadacheNervous system disorders	15/55	10/54	15/55	14/54
Nasal CongestionRespiratory, thoracic and mediastinal disorders	7/55	6/54	15/55	14/54
Chest PainRespiratory, thoracic and mediastinal disorders	14/55	3/54	1/55	1/54
Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders	7/55	2/54	10/55	3/54

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Alair Group	Control Group	Total
Mean	39.36 ± 11.18	41.65 ± 11.35	40.50 ± 11.27

Sex: Female, Male
Sex: Female, Male(Participants)	Alair Group	Control Group	Total
Female	31	31	62
Male	24	23	47

Region of Enrollment
Region of Enrollment(participants)	Alair Group	Control Group	Total
Canada	21	21	42
United Kingdom	19	17	36
Denmark	3	4	7
Brazil	12	12	24

Study locations

No study locations are listed for this record.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00214526
Lead sponsor: Asthmatx, Inc.
First posted: Sep 22, 2005
Start date: Nov 2002
Primary completion: Jul 2006
Completion: Jul 2006
Results posted: Oct 18, 2010
Last update: Aug 28, 2015

Study contacts

Narinder S Shargill, PhD

study director · Asthmatx, Inc.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Start the discussion