Research in Severe Asthma (RISA) Trial

NCT00214539 | Completed Results DMC

• 1 other identifier: Protocol #0903-27
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Asthma

Keywords

Asthma; Bronchial Thermoplasty

Outcome Measures

Primary Outcomes (1)

• Respiratory Adverse Events Per Subject

  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.

  Baseline, 12 Months

Secondary Outcomes (7)

• Use of Maintenance Medications (Change From Baseline)

  Baseline, 12 Months

• Use of Rescue Medications (Change From Baseline)

  Baseline, 12 Months

• Total Symptom Score (Change From Baseline)

  Baseline, 12 Months

• Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)

  Baseline, 12 Months

• Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline)

  Baseline, 12 Months

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Procedure: Bronchial Thermoplasty with the Alair System

Control

ACTIVE COMPARATOR

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.

Drug: Control

Interventions

Bronchial Thermoplasty with the Alair System PROCEDURE

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.

Also known as: Alair System

Treatment

Control DRUG

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Related Publications (1)

• Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.

  PMID: 17901415 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Catheter Ablation; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: G Mark Grubb, RN, CCRA
• Organization: Boston Scientific Corporation

Mark.Grubb@bsci.com

412-716-0717

Study Officials

• Narinder S Shargill, PhD

  Asthmatx, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: August 1, 2006
• Last Updated: February 11, 2021
• Results First Posted: November 7, 2011

Record last verified: 2021-01