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Asthma Intervention Research 2 (AIR2) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00231114
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : November 29, 2010
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Intervention Device: Alair System
Enrollment 297
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Alair Sham
Hide Arm/Group Description Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Period Title: Randomized
Started 196 101
Completed 190 98
Not Completed 6 3
Reason Not Completed
Withdrawal by Subject             6             3
Period Title: Treatment Period
Started 190 98
Completed 189 98
Not Completed 1 0
Reason Not Completed
Death: Motor Vehicle Accident             1             0
Period Title: Post-Treatment Period
Started 189 98
Completed 181 97
Not Completed 8 1
Reason Not Completed
Lost to Follow-up             6             1
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title Alair Sham Total
Hide Arm/Group Description Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists. Total of all reporting groups
Overall Number of Baseline Participants 190 98 288
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 190 participants 98 participants 288 participants
40.7  (11.89) 40.6  (11.85) 40.65  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 98 participants 288 participants
Female
109
  57.4%
60
  61.2%
169
  58.7%
Male
81
  42.6%
38
  38.8%
119
  41.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 190 participants 98 participants 288 participants
United States 59 29 88
Canada 36 17 53
Brazil 55 29 84
United Kingdom 28 15 43
Netherlands 5 2 7
Australia 7 6 13
1.Primary Outcome
Title Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Hide Description Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.35  (1.10) 1.16  (1.23)
2.Secondary Outcome
Title Percent Symptom-Free Days (Change From Baseline)
Hide Description Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Percent Change
24.4  (36.16) 21.0  (35.48)
3.Secondary Outcome
Title Total Symptom Score (Change From Baseline)
Hide Description Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.7  (2.32) -1.6  (2.64)
4.Secondary Outcome
Title Number of Puffs of Rescue Medication Used (Change From Baseline)
Hide Description Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Puffs/7 Days
-6.0  (16.67) -4.3  (12.19)
5.Secondary Outcome
Title Percent Days Rescue Medication Used (Change From Baseline)
Hide Description Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Percent Change
-24.0  (33.51) -22.0  (36.14)
6.Secondary Outcome
Title Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Hide Description Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) 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 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.82  (0.95) -0.77  (1.08)
7.Secondary Outcome
Title Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
Hide Description Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: L/Min
27.8  (49.78) 22.3  (51.54)
8.Secondary Outcome
Title Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Hide Description Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Percent Change
-1.4  (14.71) -0.1  (13.80)
9.Secondary Outcome
Title Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Hide Description Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Percent Change
-2.8  (10.74) -2.4  (8.33)
10.Other Pre-specified Outcome
Title Rate of Severe Exacerbations Requiring Systemic Corticosteroids
Hide Description Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Events/Subject/Year
0.48  (0.07) 0.70  (0.12)
11.Other Pre-specified Outcome
Title Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids
Hide Description Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.
Time Frame Baseline, 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Measure Type: Number
Unit of Measure: Percent of Subjects
26.3 39.8
12.Other Pre-specified Outcome
Title Days Lost From Work/School/Other Activities Due to Asthma
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Days/Subject/Year
1.32  (0.36) 3.9  (1.6)
13.Other Pre-specified Outcome
Title Unscheduled Physician Office Visits for Respiratory Symptoms
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Events/Subject/Year
0.28  (0.05) 0.36  (0.09)
14.Other Pre-specified Outcome
Title Emergency Room Visits for Respiratory Symptoms
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population. Consists of all randomized subjects who were administered at least one bronchoscopy.
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Mean (Standard Deviation)
Unit of Measure: Events/Subject/Year
0.07  (0.03) 0.43  (0.20)
15.Other Pre-specified Outcome
Title Hospitalizations for Respiratory Symptoms
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alair Sham
Hide Arm/Group Description:
Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Overall Number of Participants Analyzed 190 98
Measure Type: Number
Unit of Measure: Events/Subject/Year
0.04 0.13
Time Frame [Not Specified]
Adverse Event Reporting Description Rates in "Other Adverse Events" include Serious Adverse Events. Two subjects in the BT group did not complete the 6-week visit and were classified as having missed visits. These subjects were later classified as lost to follow-up or withdrawn. Conservatively, the lowest denominator (187 instead of 189) to estimate post-treatment risk has been used.
 
Arm/Group Title Alair (Treatment Period) Sham (Treatment Period) Alair (Post-Treatment Period) Sham (Post-Treatment Period)
Hide Arm/Group Description Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System. Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment. Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System. Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
All-Cause Mortality
Alair (Treatment Period) Sham (Treatment Period) Alair (Post-Treatment Period) Sham (Post-Treatment Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Alair (Treatment Period) Sham (Treatment Period) Alair (Post-Treatment Period) Sham (Post-Treatment Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/190 (10.00%)   4/98 (4.08%)   12/187 (6.42%)   10/98 (10.20%) 
Gastrointestinal disorders         
Abdominal Pain  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  1/98 (1.02%) 
Umbilical Hernia  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
General disorders         
Fatigue  1/190 (0.53%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Hepatobiliary disorders         
Cholecystitis Acute  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Infections and infestations         
Osteomyelitis  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Injury, poisoning and procedural complications         
Road Traffic Accident  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Thermal Burn  0/190 (0.00%)  0/98 (0.00%)  0/187 (0.00%)  1/98 (1.02%) 
Investigations         
Forced Expiratory Volume Decreased  1/190 (0.53%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back Pain  1/190 (0.53%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Chondrocalcinosis Pyrophosphate  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast Cancer Stage II  0/190 (0.00%)  0/98 (0.00%)  0/187 (0.00%)  1/98 (1.02%) 
Nervous system disorders         
Headache  0/190 (0.00%)  1/98 (1.02%)  0/187 (0.00%)  1/98 (1.02%) 
Hemiparesis  0/190 (0.00%)  0/98 (0.00%)  0/187 (0.00%)  1/98 (1.02%) 
Migraine  0/190 (0.00%)  1/98 (1.02%)  0/187 (0.00%)  1/98 (1.02%) 
Psychiatric disorders         
Depression  1/190 (0.53%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma (Multiple Symptoms)  9/190 (4.74%)  2/98 (2.04%)  5/187 (2.67%)  4/98 (4.08%) 
Atelectasis  2/190 (1.05%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Chest Pain  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Foreign Body Aspiration  1/190 (0.53%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Haemoptysis  1/190 (0.53%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Lower Respiratory Tract Infection  2/190 (1.05%)  0/98 (0.00%)  0/187 (0.00%)  0/98 (0.00%) 
Pneumonia  0/190 (0.00%)  0/98 (0.00%)  1/187 (0.53%)  0/98 (0.00%) 
Surgical and medical procedures         
Haematoma Evacuation  0/190 (0.00%)  0/98 (0.00%)  0/187 (0.00%)  1/98 (1.02%) 
Hysterectomy  0/190 (0.00%)  0/98 (0.00%)  0/187 (0.00%)  1/98 (1.02%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alair (Treatment Period) Sham (Treatment Period) Alair (Post-Treatment Period) Sham (Post-Treatment Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   176/190 (92.63%)   82/98 (83.67%)   157/187 (83.96%)   86/98 (87.76%) 
Infections and infestations         
Influenza  8/190 (4.21%)  2/98 (2.04%)  8/187 (4.28%)  12/98 (12.24%) 
Musculoskeletal and connective tissue disorders         
Back Pain  9/190 (4.74%)  6/98 (6.12%)  6/187 (3.21%)  5/98 (5.10%) 
Nervous system disorders         
Headache  27/190 (14.21%)  9/98 (9.18%)  9/187 (4.81%)  3/98 (3.06%) 
Respiratory, thoracic and mediastinal disorders         
Acute Sinusitis  5/190 (2.63%)  2/98 (2.04%)  7/187 (3.74%)  8/98 (8.16%) 
Asthma (Multiple Symptoms)  99/190 (52.11%)  38/98 (38.78%)  51/187 (27.27%)  42/98 (42.86%) 
Bronchitis  7/190 (3.68%)  2/98 (2.04%)  13/187 (6.95%)  5/98 (5.10%) 
Chest Discomfort  17/190 (8.95%)  10/98 (10.20%)  3/187 (1.60%)  1/98 (1.02%) 
Chest Pain  26/190 (13.68%)  13/98 (13.27%)  5/187 (2.67%)  1/98 (1.02%) 
Cough  23/190 (12.11%)  14/98 (14.29%)  5/187 (2.67%)  5/98 (5.10%) 
Dyspnoea  21/190 (11.05%)  6/98 (6.12%)  4/187 (2.14%)  1/98 (1.02%) 
Lower Respiratory Tract Infection  15/190 (7.89%)  2/98 (2.04%)  6/187 (3.21%)  6/98 (6.12%) 
Nasopharyngitis  9/190 (4.74%)  7/98 (7.14%)  20/187 (10.70%)  5/98 (5.10%) 
Pharyngolaryngeal Pain  6/190 (3.16%)  5/98 (5.10%)  1/187 (0.53%)  2/98 (2.04%) 
Productive Cough  14/190 (7.37%)  9/98 (9.18%)  5/187 (2.67%)  4/98 (4.08%) 
Rhinitis  3/190 (1.58%)  0/98 (0.00%)  8/187 (4.28%)  6/98 (6.12%) 
Sinusitis  6/190 (3.16%)  5/98 (5.10%)  12/187 (6.42%)  7/98 (7.14%) 
Throat Irritation  9/190 (4.74%)  12/98 (12.24%)  2/187 (1.07%)  3/98 (3.06%) 
Upper Respiratory Tract Infection  38/190 (20.00%)  11/98 (11.22%)  56/187 (29.95%)  25/98 (25.51%) 
Viral Upper Respiratory Tract Infection  8/190 (4.21%)  2/98 (2.04%)  11/187 (5.88%)  7/98 (7.14%) 
Wheezing  29/190 (15.26%)  6/98 (6.12%)  8/187 (4.28%)  3/98 (3.06%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Narinder S Shargill, PhD
Organization: Asthmatx, Inc.
Phone: 408-419-0100
Publications of Results:
Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.
Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00231114    
Other Study ID Numbers: 04-02
First Submitted: September 30, 2005
First Posted: October 4, 2005
Results First Submitted: August 31, 2010
Results First Posted: November 29, 2010
Last Update Posted: July 27, 2017