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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

  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

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 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      109  57.4%      60  61.2%      169  58.7% 
Male      81  42.6%      38  38.8%      119  41.3% 
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

1.  Primary:   Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)   [ Time Frame: Baseline, 12 Months ]
  Show Outcome Measure 1

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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

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: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00231114     History of Changes
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