Clinical trial NCT00401986: RISA Extension Study - Long Term Safety
Official title: Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Refractory Asthma
Bronchial Thermoplasty
Alair System
RISA (Research in Severe Asthma)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY (NCT00214539).

Brief summary: The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).

Detailed description: This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214539).

Enrollment will be limited to only those subjects who were treated with the Alair System in the PREDECESSOR STUDY.

Written, informed consent will be obtained from all subjects prior to performing any study procedures.

The present study will extend the follow-up evaluation of Alair-Treated Subjects from the PREDECESSOR STUDY to 5 years post-treatment with the Alair System. These evaluations will consist of four study visits corresponding to the two-year, three-year, four-year and five-year time points following completion of Alair treatments in the PREDECESSOR STUDY. For consistency with the PREDECESSOR STUDY, ideally the subject's drug therapy should continue to be consistent with GINA (Global Initiative for Asthma) Guidelines for the severity of the subject's asthma. Any changes in maintenance levels of asthma medications will be documented.

The goal of this follow-on study is to enroll all Alair-Treated Subjects who completed the PREDECESSOR STUDY. Inclusion of subjects from the treatment arm will allow for better assessment of the long-term safety of the Alair procedure.

Eligibility criteria: Inclusion Criteria:

* Subject who participated in the PREDECESSOR STUDY entitled "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair™ System for the Treatment of Severe Asthma" (Protocol # 0903-27).
* Subject was treated with the Alair System ("Alair Group") in the PREDECESSOR STUDY.
* Subject who is able to read, understand, and provide written Informed Consent.
* Subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits.

Exclusion Criteria:

* Subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period.
* Subject with a newly diagnosed (since exiting from the PREDECESSOR STUDY) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.

Primary outcomes:
measure: Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments
timeFrame: 2-year, 3-year, 4-year and 5-year follow up post procedure
measure: Respiratory Adverse Events
timeFrame: 2-year, 3-year, 4-year and 5-year follow up post procedure
Secondary outcomes:
measure: Hospitalizations for Respiratory Symptoms
timeFrame: 2-year, 3-year, 4-year and 5-year follow up post procedure
measure: Emergency Room Visits for Respiratory Symptoms
timeFrame: 2-year, 3-year, 4-year and 5-year follow up post procedure
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
state: RS
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Sainte-Foy
country: Canada
facility: Hospital Laval, University of Laval
state: Quebec
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital, Univ. Glasgow
city: Leicester
country: United Kingdom
facility: Glenfield General Hospital, Univ. Leicester
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College
city: Manchester
country: United Kingdom
facility: Northwest Lung Research Center, University of Manchester
city: Newcastle-upon-Tyne
country: United Kingdom
facility: William Leech Center, Freeman Hospital
Study officials:
affiliation: Asthmatx, Inc.
name: Narinder S Shargill, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Laviolette M, Shargill NS, Cox G; AIR Trial Study Group. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulm Med. 2011 Feb 11;11:8. doi: 10.1186/1471-2466-11-8.
citation: Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.