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
  Hide Participant Flow

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 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
  Hide Baseline Characteristics

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 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  
Number of Participants  
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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:

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