Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Bronchial thermoplasty with the Alair System
- Conditions
- Asthma
- Sponsor
- Asthmatx, Inc.
- Enrollment
- 112
- Primary Endpoint
- Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to either the Alair Group (Medical management + Alair treatment),or Control Group (Medical management only).
Detailed Description
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil). Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or Control Visit. In order to maximize the power of the study, Baseline and Follow-up testing was conducted in 2 parts. In the first part subjects continued to take their asthma maintenance medications (inhaled corticosteroids (ICS) and long acting β2-agonists (LABA) during the test period. This is designated as the "ON-LABA" Phase. Following ON-LABA testing subjects were asked to abstain from LABA for the second part of the testing, and these results are designated as the "OFF-LABA" Phase.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ambulatory adult; age 18-65 years
- •Asthma requiring regular maintenance medication that includes inhaled corticosteroid (at least 200 μg beclomethasone per day or equivalent) AND long acting ß2 agonist (LABA) (at least 100 mg salmeterol per day or equivalent)
- •Pre-bronchodilator FEV1 60-85% (patients stabilized on inhaled corticosteroids and long acting β2 agonists)
- •PC20 \< 8 mg/ml per methacholine inhalation test using standardized methods.
- •Demonstration of worsening of asthma following 2-week withdrawal of LABA, as documented by either:
- •an increase of at least 0.5 in the Juniper Asthma Control Questionnaire score, relative to the Questionnaire score in the 2 weeks preceding withdrawal of LABA, OR
- •a decline of at least 5% in the average am Peak Expiratory Flow during the second week of LABA abstinence relative to the average am Peak Expiratory Flow during the week immediately preceding LABA withdrawal
- •Non-smoker x 1 year or greater (if former smoker, less than 10 pack years total smoking history)
- •Willingness and ability to give written Informed Consent
- •Willingness and ability to comply with the study protocol, including requirements for taking and abstaining from medications.
Exclusion Criteria
- •Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of the pretreatment evaluation, or during the study period
- •Current or recent respiratory tract infection (resolved less than 6 weeks from pretreatment evaluation)
- •History of recurrent (³ 3 infections/year) lower respiratory tract infection requiring antibiotics.
- •With the exception of the use of a prophylactic bronchodilator for exercise, requirement for more than 4 puffs in a 24-hour period of a short-acting b2-adrenergic agonist such as albuterol or salbutamol 100 mg/puff or equivalent within the seven days immediately prior to commencement of Enrollment Testing, Part I.
- •Unstable asthma as defined by the need for an extra visit to a healthcare provider, increase in or introduction of new maintenance or symptom relieving medications (including new requirement for IV or nebulized medications) within 6 weeks of enrollment
- •Use of an internal or external pacemaker or internal cardiac defibrillator
- •Significant co-morbid illness such as cancer, renal failure, liver disease or cerebral vascular disease
- •POST-bronchodilator FEV1 of less than 65%.
- •Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
- •Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
Arms & Interventions
Alair Group
Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System.
Intervention: Bronchial thermoplasty with the Alair System
Control Group
Conventional therapy with ICS+LABA.
Intervention: Conventional therapy with ICS+LABA
Outcomes
Primary Outcomes
Mild Exacerbation Rate (OFF-LABA) (Change From Baseline)
Time Frame: Baseline, 12 Months
Average change from Baseline across 12-Week, 6-Month, and 12-Month (OFF-LABA) Follow-up visits. A mild exacerbation was defined as 2 consecutive days when at least one of the following occurs: 1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded during the 7 days immediately prior to Enrollment testing; 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage during the 7 days immediately prior to Enrollment testing; 3. Awakening at night with asthma symptoms.
Secondary Outcomes
- Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)
- Use of Maintenance Medications (Change From Baseline)(Baseline, 12 Months)
- Peak Expiratory Flow (Morning and Evening) (Change From Baseline)(Baseline, 12 Months)
- Asthma Control Questionnaire (ACQ) Score (Change From Baseline)(Baseline, 12 Months)
- Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline)(Baseline, 12 Months)
- Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)
- Total Symptom Score (Change From Baseline)(Baseline, 12 Months)
- Methacholine PC20 (Change From Baseline)(Baseline, 12 Months)
- Use of Rescue Medications (Change From Baseline)(Baseline, 12 Months)