NCT00401986

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
10 years until next milestone

Results Posted

Study results publicly available

February 1, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

3.9 years

First QC Date

November 17, 2006

Results QC Date

June 17, 2015

Last Update Submit

January 29, 2021

Conditions

Asthma

Keywords

Refractory AsthmaBronchial ThermoplastyAlair SystemRISA (Research in Severe Asthma)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Hospitalizations for Respiratory Symptoms

    2-year, 3-year, 4-year and 5-year follow up post procedure

  • Emergency Room Visits for Respiratory Symptoms

    2-year, 3-year, 4-year and 5-year follow up post procedure

Study Arms (1)

Alair Treatment

Alair Treated subjects from PREDECESSOR STUDY (NCT00214539).

Device: Bronchial thermoplasty with the Alair System

Interventions

Bronchial thermoplasty with the Alair SystemDEVICE

Treatment of airways with the Alair System in PREDECESSOR STUDY (NCT00214539).

Alair Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with severe asthma, previously treated with the Alair System in the PREDECESSOR STUDY (NCT00214539).

You may qualify if:

  • 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.

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90570-080, Brazil

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Hospital Laval, University of Laval

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Gartnavel General Hospital, Univ. Glasgow

Glasgow, United Kingdom

Location

Glenfield General Hospital, Univ. Leicester

Leicester, LE3 9QP, United Kingdom

Location

National Heart and Lung Institute, Imperial College

London, SW3 6NP, United Kingdom

Location

Northwest Lung Research Center, University of Manchester

Manchester, M23 9LT, United Kingdom

Location

William Leech Center, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related 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. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.

    PMID: 17901415BACKGROUND

  • 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: 21314924BACKGROUND

  • 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.

    PMID: 24125149RESULT

MeSH Terms

Conditions

Asthma

Interventions

Bronchial Thermoplasty

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Catheter AblationRadiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
G Mark Grubb, RN, CCRA
Organization
Boston Scientific Corp.
grubbm@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
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 22, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

February 1, 2021

Results First Posted

February 1, 2021

Record last verified: 2021-01

Locations

CA(2)GB(5)BR(1)