Back to resultsAsthma Intervention Research 2 (AIR2) Trial
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Alair System
Alair System
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Sites / Locations
- Pulmonary Associates, PA
- University of Southern California, Adult Asthma and Allergy Center
- National Jewish Medical and Research Center
- University of Chicago
- Peoria Pulmonary Associates, Ltd.
- University of Iowa Hospitals and Clinics
- Veritas Clinical Specialties
- Johns Hopkins University School of Medicine
- Brigham and Womens's Hospital
- Beth Israel Deaconess Medical Center
- Henry Ford Medical Center
- HealthPartners Specialty Center, Lung and Sleep Health
- Washington University School of Medicine
- Saint Vincent Catholic Medical Center
- Duke University Medical Center
- Cleveland Clinic Foundation
- Hospital of the University of Pennyslvania
- Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse
- Baylor College of Medicine
- Virginia Hospital Center
- Swedish Medical Center
- University of Wisconsin Hospital
- John Hunter Hospital
- Sir Charles Gairdner Hospital
- Royal Adelaide Hospital
- Hospital Sao Lucas da PUCRS
- Irmandade Santa Casa de Miscericordia de Porto Alegre
- Hospital Universitario Clementino Fraga Filho
- Faculdade da Medicina do ABC
- Firestone Institute of Respiratory Health, St. Joseph's Healthcare
- Montreal Chest Institute, McGill University
- Hopital Laval, Centre de Pneumologie
- Odense Universitets Hospital, University of Odense
- Universitair Medisch Centrum
- Gartnavel General Hospital, University of Glasgow
- Birmingham Heartlands Hospital
- Glenfield General Hospital, Univ. Hospitals of Leicester
- Chelsea & Westminster Healthcare NHS Trust
- Northwest Lung Research Center, Univ. of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Alair
Sham
Arm Description
Treatment of airways with the Alair System
Sham treatment of airways
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Percent Symptom-Free Days (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.
Total Symptom Score (Change From Baseline)
Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Number of Puffs of Rescue Medication Used (Change From Baseline)
Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Percent Days Rescue Medication Used (Change From Baseline)
Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.
Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Full Information
NCT ID
NCT00231114
First Posted
September 30, 2005
Last Updated
June 29, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00231114
Brief Title
Asthma Intervention Research 2 (AIR2) Trial
Official Title
Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alair
Arm Type
Experimental
Arm Description
Treatment of airways with the Alair System
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham treatment of airways
Intervention Type
Device
Intervention Name(s)
Alair System
Intervention Description
Treatment of airways with the Alair System
Intervention Type
Device
Intervention Name(s)
Alair System
Intervention Description
Sham treatment of airways with the Alair System
Primary Outcome Measure Information:
Title
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)
Description
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."
Time Frame
Baseline, 12 Months
Secondary Outcome Measure Information:
Title
Percent Symptom-Free Days (Change From Baseline)
Description
Change between Baseline and 12-month Follow-Up Visit. Symptom-Free Days were defined as days when Subject reported no cough, wheeze, breathlessness, or sputum during the daytime, and no wheeze, cough, or awakenings due to asthma symptoms during nighttime.
Time Frame
Baseline, 12 Months
Title
Total Symptom Score (Change From Baseline)
Description
Change from Baseline and 12-month Follow-Up Visit. Total Symptom Score comprises the sum of these six asthma symptom measurements: wheeze during the night, cough during the night, wheeze during the day, cough during the day, breathlessness during the day, and sputum production during the day. Each of these symptoms is scored on a scale of 0 to 3 each day by the subject. The sum of the scores for these 6 symptoms comprises the Total Symptom Score, which measures overall asthma symptoms. The maximum score possible is 18. A lower Total Symptom score represents better asthma control.
Time Frame
Baseline, 12 Months
Title
Number of Puffs of Rescue Medication Used (Change From Baseline)
Description
Change between Baseline and 12-Month Follow-up Visit. Average number of puffs per week. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Time Frame
Baseline, 12 Months
Title
Percent Days Rescue Medication Used (Change From Baseline)
Description
Change between Baseline and 12-Month Follow-up Visit. Rescue medications for asthma are short-acting beta-agonists that bring quick relief of asthma symptoms.
Time Frame
Baseline, 12 Months
Title
Asthma Control Questionnaire (ACQ) Score (Change From Baseline)
Description
Change between Baseline and 12-month Follow-Up Visit. The ACQ is a self-administered patient questionnaire that also includes the patient's FEV1 value (% Predicted) that assesses individual subject asthma control. The ACQ comprises 6 questions that relate to the patient's asthma symptoms, activity limitations, and daily rescue bronchodilator use, and FEV1. Each question is scored from 0 (Better) to 6 (Worse). A decrease in the ACQ score indicates better asthma control.
Time Frame
Baseline, 12 Months
Title
Morning Peak Expiratory Flow (amPEF) (Change From Baseline)
Description
Change between Baseline and 12-month Follow-Up Visit. The peak expiratory flow rate measures the maximal rate at which a person can exhale air.
Time Frame
Baseline, 12 Months
Title
Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Description
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Time Frame
Baseline, 12 Months
Title
Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)
Description
Change between Baseline and 12-month Follow-Up Visit. The FEV1 is the volume of air expired during the first second of a maximal effort expiration started at total lung capacity.
Time Frame
Baseline, 12 Months
Other Pre-specified Outcome Measures:
Title
Rate of Severe Exacerbations Requiring Systemic Corticosteroids
Description
Rate of occurrence of worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.
Time Frame
Baseline, 12 Months
Title
Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids
Description
Percent of subjects experiencing worsening of asthma requiring treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a Subject taking maintenance oral corticosteroids at Study entry.
Time Frame
Baseline, 12 Months
Title
Days Lost From Work/School/Other Activities Due to Asthma
Time Frame
12 Months
Title
Unscheduled Physician Office Visits for Respiratory Symptoms
Time Frame
12 Months
Title
Emergency Room Visits for Respiratory Symptoms
Time Frame
12 Months
Title
Hospitalizations for Respiratory Symptoms
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narinder S Shargill, PhD
Organizational Affiliation
Asthmatx, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
University of Southern California, Adult Asthma and Allergy Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Peoria Pulmonary Associates, Ltd.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Veritas Clinical Specialties
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Brigham and Womens's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
HealthPartners Specialty Center, Lung and Sleep Health
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Saint Vincent Catholic Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Hospital of the University of Pennyslvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Hospital Center
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205-3698
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Hospital Sao Lucas da PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
CEP 90610-00
Country
Brazil
Facility Name
Irmandade Santa Casa de Miscericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
CEP 90035-074
Country
Brazil
Facility Name
Hospital Universitario Clementino Fraga Filho
City
Rio de Janeiro
Country
Brazil
Facility Name
Faculdade da Medicina do ABC
City
Sao Paulo
ZIP/Postal Code
CEP 09060-650
Country
Brazil
Facility Name
Firestone Institute of Respiratory Health, St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Montreal Chest Institute, McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Hopital Laval, Centre de Pneumologie
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4GS
Country
Canada
Facility Name
Odense Universitets Hospital, University of Odense
City
Odense
ZIP/Postal Code
5000 Odense C
Country
Denmark
Facility Name
Universitair Medisch Centrum
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Gartnavel General Hospital, University of Glasgow
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Glenfield General Hospital, Univ. Hospitals of Leicester
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Chelsea & Westminster Healthcare NHS Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Northwest Lung Research Center, Univ. of Manchester
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24125149
Citation
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.
Results Reference
background
PubMed Identifier
23998657
Citation
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.
Results Reference
result
PubMed Identifier
19815809
Citation
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.
Results Reference
result
PubMed Identifier
21704887
Citation
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.
Results Reference
derived
Links:
URL
http://clinicaltrials.gov/ct2/show/NCT01350414?term=PAS1&rank=1
Description
The AIR2 Extension Study (PAS1) contains the Year 2 to Year 5 Study Results.
Learn more about this trial
Asthma Intervention Research 2 (AIR2) Trial
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