AIR Extension Study - Long-Term Safety of Alair Treated Subjects

NCT00448812 | Completed Results DMC

• 1 other identifier: 05-01
• Study Type: interventional
• Target: 69
• Locations: 3 countries
• Sites: 5

Brief Summary

The primary purpose of this study is to gather additional safety data for subjects who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma" (Protocol #0602-20, NCT00214526) sponsored by Asthmatx, Inc. Study Subjects who were assigned to the Control Group who elect to participate in this extension study will be followed for an additional two (2) - year period beyond the PREDECESSOR STUDY'S one-year endpoint. Subjects treated with the Alair System who elect to participate in this extension study will be followed for an additional four (4)- year period beyond the PREDECESSOR STUDY'S one-year endpoint. All treatments with the Alair System were completed in the PREDECESSOR STUDY (NCT00214526). The current study is designed solely to collect longer-term follow-up data on the effects of the treatments. The data will be of the same type that was collected in the PREDECESSOR STUDY (NCT00214526), including spirometry, physical examinations, review of symptoms, use of maintenance and rescue medications, and response to Methacholine challenge.

Conditions

Asthma

Keywords

Alair System; Bronchial Thermoplasty; Long-term Safety

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Any Respiratory Adverse Event

  There is not one specific primary outcome measure. The primary objective of this study is to gather additional, longer-term safety data in subjects who participated in the AIR Trial (Protocol #0602-20), called the AIR PREDECESSOR STUDY in the AIR Extension Report (NCT00214526). The 'Percentage of Subjects with any Respiratory Adverse Event' was chosen to be the primary outcome measure because it is the first described in the final study report.

  12 Month periods out to 5 years

Other Outcomes (3)

• Health Care Usage

  12 Month periods out to 5 years

• Number of Respiratory Adverse Events

  12 Month periods out to 5 years

• Forced Expiratory Volume in 1 Second (FEV1) - % Predicted

  12 Month periods out to 5 years

Study Arms (2)

Alair Treatment

EXPERIMENTAL

Subjects from PREDECESSOR STUDY (NCT00214526) treated with conventional therapy with ICS+LABA (inhaled corticosteroid + long-acting beta-agonist) plus Bronchial Thermoplasty with the Alair System.

Device: Bronchial Thermoplasty with the Alair System

Control

NO INTERVENTION

Control group subjects from PREDECESSOR STUDY (NCT00214526).

Interventions

Bronchial Thermoplasty with the Alair System DEVICE

Treatment of airways with the Alair System (Bronchial Thermoplasty) in the PREDECESSOR STUDY (NCT00214526).

Alair Treatment

Eligibility Criteria

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

You may qualify if:

• Subject who participated in the PREDECESSOR STUDY entitled "Multicenter Randomized Clinical Trial of the Alair System for the Bronchial Thermoplasty Treatment of Asthma"(Protocol # 0602-20, NCT00214526).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, CEP 90035 074, Brazil

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Hopital Laval, Laval University

Sainte-Foy, Quebec, G1V 4GS, Canada

Location

Gartnavel General Hospital, Univ. Glasgow

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Northwest Lung Research Center, Univ. Manchester

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21314924 RESULT

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 Corp.

grubbm@bsci.com

+1 (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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2021-01

Locations

BR (1); CA (2); GB (2)