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Completed

NCT Number: NCT03243292

Bronchial Thermoplasty 10+ Year Study

To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.

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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

Sex eligibility

All sexes

Study type

Observational

Primary location

Imandade Santa Casa de Misercordia, Pôrto Alegre, Rio Grande do Sul, Brazil

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About this study

Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.

Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects previously enrolled in AIR, RISA or AIR2
  • Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
  • Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
  • Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements

Exclusion criteria

  • Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.

Treatment and study plan

Bronchial Thermoplasty

Other

patients had radio frequency ablation of the smooth muscle for asthma

Primary outcomes

  1. Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.

    Time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.

    Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.

  2. Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.

    Time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.

    Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.

Secondary outcomes

  1. Severe asthma exacerbation rates exacerbations

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  2. Severe asthma exacerbation rates subject

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  3. Severe asthma exacerbation rates year

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  4. rates of emergency room visits for respiratory adverse events

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  5. proportion of subjects with emergency room visits for respiratory adverse events

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  6. Rates of hospitalizations for respiratory adverse events

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  7. Proportion of subjects with hospitalizations for respiratory adverse events

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  8. Rates of Respiratory Serious Adverse Events (SAEs)

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

  9. Proportion of subjects with respiratory SAEs)

    Time frame: One day visit

    evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Jul 13, 2020

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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