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Asthma Intervention Research 2 (AIR2) Trial

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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

Tracking Information
First Submitted Date  ICMJE September 30, 2005
First Posted Date  ICMJE October 4, 2005
Results First Submitted Date  ICMJE August 31, 2010
Results First Posted Date  ICMJE November 29, 2010
Last Update Posted Date July 27, 2017
Study Start Date  ICMJE September 2005
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) [ Time Frame: Baseline, 12 Months ]
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."
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
The difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and follow-up visits.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • Percent Symptom-Free Days (Change From Baseline) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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) [ Time Frame: Baseline, 12 Months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2005)
  • · Percent of Symptom Free Days
  • . Symptom scores
  • · Morning Peak Expiratory Flow (amPEF)
  • · Asthma Control Questionnaire (ACQ) score
  • · Number of puffs of rescue medication used
  • · Percent Days rescue medication was used
  • · Forced Expiratory Volume in one second (FEV1)
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2010)
  • Rate of Severe Exacerbations Requiring Systemic Corticosteroids [ Time Frame: Baseline, 12 Months ]
    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.
  • Percentage of Subjects With Severe Exacerbations Requiring Systemic Corticosteroids [ Time Frame: Baseline, 12 Months ]
    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.
  • Days Lost From Work/School/Other Activities Due to Asthma [ Time Frame: 12 Months ]
  • Unscheduled Physician Office Visits for Respiratory Symptoms [ Time Frame: 12 Months ]
  • Emergency Room Visits for Respiratory Symptoms [ Time Frame: 12 Months ]
  • Hospitalizations for Respiratory Symptoms [ Time Frame: 12 Months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asthma Intervention Research 2 (AIR2) Trial
Official Title  ICMJE Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Device: Alair System
    Treatment of airways with the Alair System
  • Device: Alair System
    Sham treatment of airways with the Alair System
Study Arms  ICMJE
  • Experimental: Alair
    Treatment of airways with the Alair System
    Intervention: Device: Alair System
  • Sham Comparator: Sham
    Sham treatment of airways
    Intervention: Device: Alair System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2010)
297
Original Enrollment  ICMJE
 (submitted: September 30, 2005)
300
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   Canada,   Denmark,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00231114
Other Study ID Numbers  ICMJE 04-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Narinder S Shargill, PhD Asthmatx, Inc.
PRS Account Boston Scientific Corporation
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP