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Completed

NCT Number: NCT00401986

RISA Extension Study - Long Term Safety

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bronchial Thermoplasty with the Alair System

Device

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

Primary outcomes

  1. Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments

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

    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. Respiratory Adverse Events

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

    Pull down menu does not have a rate unit. Numbers reported represents Rate of Respiratory Adverse (number of Events/number of Subject/year).

Secondary outcomes

  1. Hospitalizations for Respiratory Symptoms

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

    Pull down menu does not have a rate unit. Rate of Hospitalizations for Respiratory Symptoms (number of Events/number of Subject/year)

  2. Emergency Room Visits for Respiratory Symptoms

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

    Pull down menu does not have a rate unit. Rate of Emergency Room Visits for Respiratory Symptoms (number of Events/number of Subjects/year)

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 22, 2006
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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