RISA Extension Study - Long Term Safety

Asthma Clinical Trial

Official title:

Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401986
• Other study ID #: 06-01
• Status: Completed
• Start date: January 2007
• Est. completion date: February 2011

Study information

• Verified date: January 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Bronchial thermoplasty with the Alair System
Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).

Locations

Country	Name	City	State
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Canada	St. Joseph's Healthcare	Hamilton	Ontario
Canada	Hospital Laval, University of Laval	Sainte-Foy	Quebec
United Kingdom	Gartnavel General Hospital, Univ. Glasgow	Glasgow
United Kingdom	Glenfield General Hospital, Univ. Leicester	Leicester
United Kingdom	National Heart and Lung Institute, Imperial College	London
United Kingdom	Northwest Lung Research Center, University of Manchester	Manchester
United Kingdom	William Leech Center, Freeman Hospital	Newcastle-upon-Tyne

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Brazil,  Canada,  United Kingdom, 

References & Publications (3)

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. Epub 2007 Sep 27. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments	The respiratory-related adverse event profile for the Alair group was analyzed on an annual basis in order to highlight trends in adverse occurrence.	2-year, 3-year, 4-year and 5-year follow up post procedure
Primary	Respiratory Adverse Events	Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year).	2-year, 3-year, 4-year and 5-year follow up post procedure
Secondary	Hospitalizations for Respiratory Symptoms	Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year)	2-year, 3-year, 4-year and 5-year follow up post procedure
Secondary	Emergency Room Visits for Respiratory Symptoms	Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year)	2-year, 3-year, 4-year and 5-year follow up post procedure