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New treatment option for Asthma Exacerbations
Official title Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era
ClinicalTrials.gov ID: NCT07292805
What this study is testing
- What it's testing
- Rationale: For patients with severe asthma that remain uncontrolled with exacerbations despite biologics or patients who are not eligible for biologics, there is no reimbursed treatment other than pulmonary rehabilitation in the Netherlands. Pulmonary rehabilitation is known to have a limited effect for a limited amount of time.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- adult (\>18 years)
- severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy...
- 1 or more trials of treatment with a biologic or ineligible for biologic treatment
- 2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least...
- FEV1 ≥ 50% predicted after 400μg inhaled salbutamol or equivalent
You likely can't join if
- chronic OCS therapy at a dose \>20 mg/day prednisone equivalent
- 1 or more ICU admission for mechanical or endotracheal intubation for
- asthma in the previous year.
- anti-coagulation therapy that cannot be stopped temporarily
- pregnancy
- body mass index ≥35
See the full eligibility criteria
- adult (\>18 years)
- severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy compliance and adequate inhalation technique confirmed)
- 1 or more trials of treatment with a biologic or ineligible for biologic treatment
- 2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least 3 consecutive days)
- FEV1 ≥ 50% predicted after 400μg inhaled salbutamol or equivalent
- chronic OCS therapy at a dose \>20 mg/day prednisone equivalent
- 1 or more ICU admission for mechanical or endotracheal intubation for
- asthma in the previous year.
- anti-coagulation therapy that cannot be stopped temporarily
- pregnancy
- body mass index ≥35
- current or ex-smokers with \>20 pack years
- DLCOc \<70%
- Subject has a known sensitivity to medications required to perform bronchoscopy
- Subject is using immunosuppressant therapy other than oral steroid therapy that impact on BT
- Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2 or known coagulopathy
- Comorbidities that are a contra-indication for BT such as severe heart failure and other respiratory diseases including bronchiectasis, interstitial lung disease, emphy-sema, cystic fibrosis, mechanical upper airway...
- Subject uses an internal or external pacemaker or cardiac defibrillator..
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
- Groningen, Netherlands
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands; Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.