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Asthma Intervention Research 2 (AIR2) Trial

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Asthmatx, Inc.
ClinicalTrials.gov Identifier:
NCT00231114
First received: September 30, 2005
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: August 31, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Intervention: Device: Alair System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Alair Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.

Participant Flow for 3 periods

Period 1:   Randomized
    Alair   Sham
STARTED   196   101 
COMPLETED   190   98 
NOT COMPLETED   6   3 
Withdrawal by Subject                6                3 

Period 2:   Treatment Period
    Alair   Sham
STARTED   190   98 
COMPLETED   189   98 
NOT COMPLETED   1   0 
Death: Motor Vehicle Accident                1                0 

Period 3:   Post-Treatment Period
    Alair   Sham
STARTED   189   98 
COMPLETED   181   97 
NOT COMPLETED   8   1 
Lost to Follow-up                6                1 
Physician Decision                1                0 
Withdrawal by Subject                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Alair Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Sham Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
Total Total of all reporting groups

Baseline Measures
   Alair   Sham   Total 
Overall Participants Analyzed 
[Units: Participants]
 190   98   288 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.7  (11.89)   40.6  (11.85)   40.65  (11.86) 
Gender 
[Units: Participants]
     
Female   109   60   169 
Male   81   38   119 
Region of Enrollment 
[Units: 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
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1.  Primary:   Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

2.  Secondary:   Percent Symptom-Free Days (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

3.  Secondary:   Total Symptom Score (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

4.  Secondary:   Number of Puffs of Rescue Medication Used (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

5.  Secondary:   Percent Days Rescue Medication Used (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

6.  Secondary:   Asthma Control Questionnaire (ACQ) Score (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

7.  Secondary:   Morning Peak Expiratory Flow (amPEF) (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

8.  Secondary:   Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

9.  Secondary:   Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

10.  Other Pre-specified:   Rate of Severe Exacerbations Requiring Systemic Corticosteroids   [ Time Frame: Baseline, 12 Months ]

11.  Other Pre-specified:   Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids   [ Time Frame: Baseline, 12 Months ]

12.  Other Pre-specified:   Days Lost From Work/School/Other Activities Due to Asthma   [ Time Frame: 12 Months ]

13.  Other Pre-specified:   Unscheduled Physician Office Visits for Respiratory Symptoms   [ Time Frame: 12 Months ]

14.  Other Pre-specified:   Emergency Room Visits for Respiratory Symptoms   [ Time Frame: 12 Months ]

15.  Other Pre-specified:   Hospitalizations for Respiratory Symptoms   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Narinder S Shargill, PhD
Organization: Asthmatx, Inc.
phone: 408-419-0100


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Asthmatx, Inc.
ClinicalTrials.gov Identifier: NCT00231114     History of Changes
Other Study ID Numbers: 04-02
Study First Received: September 30, 2005
Results First Received: August 31, 2010
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration