Multicenter Randomized Clinical Trial of Bronchial Thermoplasty With the Alair System for the Treatment of Severe Asthma
Overview
- Phase
- Not Applicable
- Intervention
- Bronchial Thermoplasty with the Alair System
- Conditions
- Asthma
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 34
- Primary Endpoint
- Respiratory Adverse Events Per Subject
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma.
This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to standard medication therapy. A total of 30 subjects will be randomized 1:1 to the Alair Group (Medical management + Alair Treatment) OR the Control Group (Medical management only).
Detailed Description
Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries. Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the 3 treatment bronchoscopy sessions. Following completion of all three procedures or Control Visits subjects will be evaluated at 6 weeks and 12 weeks. All subjects to remain on their maintenance asthma medications until they are evaluated again at 22 weeks after the last procedure or Control Visit. This phase from the last procedure or Control Visit out to 22 Weeks after the last procedure or Control Visit is termed the Steroid Stable Phase. Subjects will undergo a 14 week period from 22 Weeks to 36 Weeks (termed the Steroid Wean Phase) during which an attempt will be made to wean them off either their maintenance inhaled corticosteroids (ICS) or, if taking maintenance oral corticosteroids (OCS), their oral steroids. If a subject cannot tolerate the steroid reduction at a particular level (as evidenced by loss of asthma control), they will be stabilized on their last tolerable dose of steroid. All subjects will maintain their reduced steroid dosage from the end of the Steroid Wean Phase at 36 weeks to their final evaluations at the end of the Study at 52 weeks (termed the Reduced Steroid Phase). All subjects will be exited from the study following completion of the 52 week evaluations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Ambulatory adult; age 18-65 years
- •Asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid AND long acting β2 agonist (LABA) with or without other asthma maintenance medications. Oral prednisone ≤30 mg/day, leukotriene modifiers, theophylline or other asthma control drugs may be prescribed at the physician's discretion.
- •Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥50% predicted (patients stabilized on inhaled corticosteroids (ICS) and long acting β2 agonists)
- •PC20 \< 4 mg/ml per methacholine inhalation test using standardized methods, for patients with pre-bronchodilator FEV1 ≥60% predicted (or FEV1 \> lower limit defined by individual hospital protocol). PC20 is the provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline
- •Reversible bronchoconstriction during the 12 months prior to enrollment, as demonstrated by an increase in FEV1 of at least 12% 30 minutes after 4 puffs of short-acting β2 agonist, for patients with pre-bronchodilator FEV1 \< 60% predicted (or FEV1 \< lower limit defined by individual hospital protocol)
- •Patient must be symptomatic, despite medication with high dose inhaled corticosteroids and LABA, by at least one of the following:
- •Use of rescue medication (short-acting β2 agonist) at least 8 of the 14 days prior to enrollment OR
- •Daytime symptoms at least 10 of the 14 days prior to enrollment
- •Non-smoker x 1 year or greater (if former smoker, less than 10 pack years total smoking history)
- •Patient must be suitable for bronchoscopy in the opinion of the investigator or per hospital guidelines
Exclusion Criteria
- •Participation in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, within 6 weeks prior to randomization. Patients will be disqualified from the study if they enter another study or fail to comply with prescribed asthma medications.
- •Use of immunosuppressant therapy (e.g., methotrexate).
- •Current or recent lower respiratory tract infection (resolved less than 6 weeks from enrollment testing)
- •History of recurrent (no more than three in the last three months) lower respiratory tract infection requiring antibiotics
- •Presence of other respiratory diseases including emphysema, cystic fibrosis, vocal cord dysfunction, mechanical upper airway obstruction, obstructive sleep apnea, Churg-Strauss syndrome, cardiac dysfunction, allergic bronchopulmonary aspergillosis
- •DLCO (diffusion capacity) \< 70% predicted
- •Uncontrolled sinus disease
- •Uncontrolled gastro-esophageal reflux disease
- •Use of implanted electronic device such as a pacemaker or internal cardiac defibrillator
- •Use of external pacemaker
Arms & Interventions
Treatment
Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day.
Intervention: Bronchial Thermoplasty with the Alair System
Control
Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤30 mg/day.
Intervention: Control
Outcomes
Primary Outcomes
Respiratory Adverse Events Per Subject
Time Frame: Baseline, 12 Months
Respiratory adverse events (AEs) per subject reported during the Treatment Period, and Post-Treatment Period (Steroid Stable Phase, and Steroid Wean and Reduced Steroid Phase). Results were calculated by dividing the number of respiratory adverse events during each time period by the number of subjects in each group. Statistics were not calculated.
Secondary Outcomes
- Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)
- Use of Maintenance Medications (Change From Baseline)(Baseline, 12 Months)
- Total Symptom Score (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)
- Use of Rescue Medications (Change From Baseline)(Baseline, 12 Months)
- Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)(Baseline, 12 Months)