Research in Severe Asthma (RISA) Trial

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asthmatx, Inc.; Boston Scientific Corporation

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:

1. Use of rescue medication (short-acting β2 agonist) at least 8 of the 14 days prior to enrollment OR

2. 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 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

• 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.