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Completed

NCT Number: NCT02104856

Bronchial Thermoplasty Global Registry

The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

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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

Macquarie University Private Hospital, North Ryde, New South Wales, Australia

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About this study

This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.

The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.

The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
  • Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.

Exclusion criteria

  • Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.

Treatment and study plan

Alair System (Bronchial Thermoplasty)

Device

Primary outcomes

  1. Proportion of patients who experience severe asthma exacerbations

    Time frame: 2 years

    The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.

Secondary outcomes

  1. Asthma Quality of Life Questionnaire (AQLQ) score

    Time frame: 2 years

    Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

  2. Asthma Control Test (ACT) score

    Time frame: 2 years

    Change from baseline in Asthma Control Test (ACT) scores will be summarized descriptively for Year 1 and Year 2 post-BT.

  3. Emergency department visits for asthma symptoms

    Time frame: 2 years

    Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.

  4. Hospitalizations for asthma symptoms

    Time frame: 2 years

    Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.

  5. Unscheduled office visits including urgent care visits for asthma symptoms.

    Time frame: 2 years

    Will be summarized both by the incidence (percentage of subjects reporting at least one event) and event rates (events/subject/year) for 1 and 2 Years post-BT.

  6. Pre- and post-bronchodilator Forced Expiratory Volume in one minute (FEV1)

    Time frame: 2 years

    Pre- and post-bronchodilator FEV1 will be summarized for Year 1 and Year 2 post-BT treatment (% predicted and absolute value). Change from baseline will also be summarized.

  7. Respiratory Adverse Events

    Time frame: 2 years

    Separated by treatment period and post-treatment period

  8. Lung Volumes

    Time frame: 2 years

    Collected at sites where it is standard of care

  9. Diffusion Capacity

    Time frame: 2 years

    Collected at sites where it is standard of care

  10. Asthma maintenance medication use (Long Acting Beta Agonists, steroids etc.)

    Time frame: 2 years

    Collect asthma maintenance medications at all sites

  11. Patient satisfaction survey score

    Time frame: 2 years

    Two question survey collected at 12 month and 24 month annual visit

  12. Allergic skin test or Radioallergosorbent Test (RAST) (perennial, seasonal, mold)

    Time frame: 2 years

    Collected at sites where it is standard of care

  13. Sputum eosinophils

    Time frame: 2 years

    Collected at sites where it is standard of care

  14. Exhaled nitric oxide (eNO)

    Time frame: 2 years

    Collected at sites where it is standard of care

  15. Methacholine challenge (Methacholine PC20)

    Time frame: 2 years

    Collected at sites where it is standard of care

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Bronchial Thermoplasty (BT) Global Registry

Acronym: BTGR

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2014
Registry last updated
Sep 13, 2019

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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