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

History of Changes

Results First Received: August 31, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, 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 ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Other Pre-specified:

Rate of Severe Exacerbations Requiring Systemic Corticosteroids [ Time Frame: Baseline, 12 Months ]

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11. Other Pre-specified:

Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids [ Time Frame: Baseline, 12 Months ]

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12. Other Pre-specified:

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

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13. Other Pre-specified:

Unscheduled Physician Office Visits for Respiratory Symptoms [ Time Frame: 12 Months ]

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14. Other Pre-specified:

Emergency Room Visits for Respiratory Symptoms [ Time Frame: 12 Months ]

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15. Other Pre-specified:

Hospitalizations for Respiratory Symptoms [ Time Frame: 12 Months ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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:

Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.

Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.

Other Publications:

Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.

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

Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.

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

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