Asthma Intervention Research (AIR) Trial

This study has been completed.
Sponsor:
Information provided by:
Asthmatx, Inc.
ClinicalTrials.gov Identifier:
NCT00214526
First received: September 15, 2005
Last updated: October 28, 2010
Last verified: October 2010
Results First Received: September 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Procedure: Bronchial thermoplasty with the Alair System
Drug: Conventional therapy with ICS+LABA

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alair Group Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
Control Group Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.

Participant Flow for 3 periods

Period 1:   Randomized
    Alair Group     Control Group  
STARTED     56     56  
COMPLETED     55     54  
NOT COMPLETED     1     2  

Period 2:   Treatment Period
    Alair Group     Control Group  
STARTED     55     54  
COMPLETED     53     49  
NOT COMPLETED     2     5  

Period 3:   Post-Treatment Period
    Alair Group     Control Group  
STARTED     53     49  
COMPLETED     52     49  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Alair Group Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
Control Group Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
Total Total of all reporting groups

Baseline Measures
    Alair Group     Control Group     Total  
Number of Participants  
[units: participants]
  55     54     109  
Age  
[units: years]
Mean ± Standard Deviation
  39.36  ± 11.18     41.65  ± 11.35     40.50  ± 11.27  
Gender  
[units: participants]
     
Female     31     31     62  
Male     24     23     47  
Region of Enrollment  
[units: participants]
     
Canada     21     21     42  
United Kingdom     19     17     36  
Denmark     3     4     7  
Brazil     12     12     24  



  Outcome Measures
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1.  Primary:   Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

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

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

4.  Secondary:   Methacholine PC20 (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

5.  Secondary:   Peak Expiratory Flow (Morning and Evening) (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:   Use of Rescue Medications (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

8.  Secondary:   Use of Maintenance Medications (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

9.  Secondary:   Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]

10.  Secondary:   Total Symptom Score (Change From Baseline)   [ Time Frame: Baseline, 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


No publications provided by Asthmatx, Inc.

Publications automatically indexed to this study:

Responsible Party: Narinder S Shargill, PhD., Vice President, Clinical Affairs, Asthmatx, Inc.
ClinicalTrials.gov Identifier: NCT00214526     History of Changes
Other Study ID Numbers: Protocol #0602-20
Study First Received: September 15, 2005
Results First Received: September 8, 2010
Last Updated: October 28, 2010
Health Authority: Canada: Health Canada