Status:
COMPLETED
Research in Severe Asthma (RISA) Trial
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
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 t...
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, wh...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Significant co-morbid illness such as cancer, renal failure, liver disease or cerebral vascular disease
- Post-bronchodilator FEV1 of less than 55% predicted
- Known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents
- Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, benzodiazepines and opioids
- Use of a systemic b-adrenergic blocking agent
- Other medical criteria.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00214539
Start Date
April 1 2004
End Date
August 1 2006
Last Update
February 11 2021
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