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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00231114




Registration number
NCT00231114
Ethics application status
Date submitted
30/09/2005
Date registered
4/10/2005
Date last updated
27/07/2017

Titles & IDs
Public title
Asthma Intervention Research 2 (AIR2) Trial
Scientific title
Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Secondary ID [1] 0 0
04-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Alair System
Treatment: Devices - Alair System

Experimental: Alair - Treatment of airways with the Alair System

Sham Comparator: Sham - Sham treatment of airways


Treatment: Devices: Alair System
Treatment of airways with the Alair System

Treatment: Devices: Alair System
Sham treatment of airways with the Alair System

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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."
Timepoint [1] 0 0
Baseline, 12 Months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline, 12 Months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline, 12 Months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline, 12 Months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline, 12 Months
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline, 12 Months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline, 12 Months
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline, 12 Months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline, 12 Months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2035 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
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Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Brazil
State/province [21] 0 0
RS
Country [22] 0 0
Brazil
State/province [22] 0 0
Porto Alegre
Country [23] 0 0
Brazil
State/province [23] 0 0
Rio de Janeiro
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Denmark
State/province [27] 0 0
Odense
Country [28] 0 0
Netherlands
State/province [28] 0 0
Groningen
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Scotland
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Birmingham
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Leicester
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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 ß2-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 ß2-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).
Trial website
https://clinicaltrials.gov/show/NCT00231114
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Narinder S Shargill, PhD
Address 0 0
Asthmatx, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications