Asthma Intervention Research 2 (AIR2) Trial
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ClinicalTrials.gov Identifier: NCT00231114 |
Recruitment Status :
Completed
First Posted : October 4, 2005
Results First Posted : November 29, 2010
Last Update Posted : July 27, 2017
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Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Asthma |
Intervention |
Device: Alair System |
Enrollment | 297 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Alair | Sham |
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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 |
Baseline Characteristics
Arm/Group Title | Alair | Sham | Total | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 190 participants | 98 participants | 288 participants | |
Female |
109 57.4%
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60 61.2%
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169 58.7%
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Male |
81 42.6%
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38 38.8%
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119 41.3%
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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 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Narinder S Shargill, PhD |
Organization: | Asthmatx, Inc. |
Phone: | 408-419-0100 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |