Asthma Intervention Research 2 (AIR2) Trial

NCT00231114 | Completed Results DMC

• 1 other identifier: 04-02
• Study Type: interventional
• Target: 297
• Locations: 7 countries
• Sites: 39

Brief Summary

The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists. The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits. All other outcome measures assessed at 12 months post-treatment. This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA). A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)

  Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."

  Baseline, 12 Months

Secondary Outcomes (8)

• Percent Symptom-Free Days (Change From Baseline)

  Baseline, 12 Months

• Total Symptom Score (Change From Baseline)

  Baseline, 12 Months

• Number of Puffs of Rescue Medication Used (Change From Baseline)

  Baseline, 12 Months

• Percent Days Rescue Medication Used (Change From Baseline)

  Baseline, 12 Months

• Asthma Control Questionnaire (ACQ) Score (Change From Baseline)

  Baseline, 12 Months

Other Outcomes (6)

• Rate of Severe Exacerbations Requiring Systemic Corticosteroids

  Baseline, 12 Months

• Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids

  Baseline, 12 Months

• Days Lost From Work/School/Other Activities Due to Asthma

  12 Months

Study Arms (2)

Alair

EXPERIMENTAL

Treatment of airways with the Alair System

Device: Alair System

Sham

SHAM COMPARATOR

Sham treatment of airways

Device: Alair System

Interventions

Alair System DEVICE

Treatment of airways with the Alair System

Alair

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is an adult between the ages of 18 to 65 years.
• Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
• Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
• Subject has a PC20 \< 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
• Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
• Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).

You may not qualify if:

• Subject has a Post-bronchodilator FEV1 of less than 65%.
• Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
• Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
• Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
• Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
• Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
• Subject has other medical criteria.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (39)

Pulmonary Associates, PA

Phoenix, Arizona, 85020, United States

Location

University of Southern California, Adult Asthma and Allergy Center

Los Angeles, California, 90033, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Peoria Pulmonary Associates, Ltd.

Peoria, Illinois, 61603, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Veritas Clinical Specialties

Topeka, Kansas, 66606, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Brigham and Womens's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

HealthPartners Specialty Center, Lung and Sleep Health

Saint Paul, Minnesota, 55101, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110-1093, United States

Location

Saint Vincent Catholic Medical Center

New York, New York, 10011, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennyslvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse

Knoxville, Tennessee, 37920, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Hospital Center

Arlington, Virginia, 22205-3698, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2035, Australia

Location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

Royal Adelaide Hospital

Adelaide, Australia

Location

Hospital Sao Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, CEP 90610-00, Brazil

Location

Irmandade Santa Casa de Miscericordia de Porto Alegre

Porto Alegre, CEP 90035-074, Brazil

Location

Hospital Universitario Clementino Fraga Filho

Rio de Janeiro, Brazil

Location

Faculdade da Medicina do ABC

São Paulo, CEP 09060-650, Brazil

Location

Firestone Institute of Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Montreal Chest Institute, McGill University

Montreal, Quebec, H2X 2P4, Canada

Location

Hopital Laval, Centre de Pneumologie

Sainte-Foy, Quebec, G1V 4GS, Canada

Location

Odense Universitets Hospital, University of Odense

Odense, 5000 Odense C, Denmark

Location

Universitair Medisch Centrum

Groningen, 9700 RB, Netherlands

Location

Gartnavel General Hospital, University of Glasgow

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Glenfield General Hospital, Univ. Hospitals of Leicester

Leicester, LE3 9QP, United Kingdom

Location

Chelsea & Westminster Healthcare NHS Trust

London, SW10 9NH, United Kingdom

Location

Northwest Lung Research Center, Univ. of Manchester

Manchester, M23 9LT, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 24125149 BACKGROUND

• 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.

  PMID: 23998657 RESULT

• 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.

  PMID: 19815809 RESULT

• 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.

  PMID: 21704887 DERIVED

Related Links

• The AIR2 Extension Study (PAS1) contains the Year 2 to Year 5 Study Results.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Narinder S Shargill, PhD
• Organization: Asthmatx, Inc.

408-419-0100

Study Officials

• Narinder S Shargill, PhD

  Asthmatx, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: April 1, 2013
• Last Updated: July 27, 2017
• Results First Posted: November 29, 2010

Record last verified: 2014-03

Locations

BR (4); US (22); CA (3); DK (1); GB (5); AU (3); NL (1)