Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation (NCT02618551) | Clinical Trial Compass
CompletedNot Applicable
Bronchial Thermoplasty for Severe Asthma With Dynamic Hyperinflation
France14 participantsStarted 2015-11
Plain-language summary
Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.
This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe asthma, uncontrolled despite optimal treatment according to GINA (global initiative for asthma) recommendations
* At least 2 exacerbations treated by systemic steroids in the last year
* FEV1 between 40 and 80% of predicted values and dynamic hyperinflation (defined as a decrease in inspiratory capacity by more than 500 ml during exercise)
Exclusion Criteria:
* Current asthma exacerbation or respiratory infection
* History of exacerbation after bronchoscopy
* FEV1 \< 40% of predicted values
* Oxygen saturation \< 90%
* Contra-indications to ALAIR catheter system : pacemaker or other electronic implanted device
* Allergy to Remifentanyl or Propofol
* pregnancy; breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial looked at bronchial thermoplasty specifically in patients with severe asthma who also have dynamic hyperinflation — does my breathing pattern match that profile, and would that make thermoplasty worth discussing as an option for me?
2Since this study is completed but focused on measuring how dynamic hyperinflation changes after bronchial thermoplasty, have the results been published yet, and what did they show about whether the procedure actually reduced air trapping?
3Bronchial thermoplasty is a bronchoscopic procedure that uses heat to reduce airway smooth muscle — what are the known risks of the procedure itself, and how do those risks compare to staying on my current medication regimen?
4This trial was listed as Phase NA, meaning it wasn't a standard drug trial testing a new treatment for the first time — can you explain what that means for how much we already know about the safety and effectiveness of bronchial thermoplasty in people like me?
5Before considering a procedure like bronchial thermoplasty, are there other steps in managing severe asthma — like biologics or optimizing my current inhalers — that you'd want to try first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.