Status:
COMPLETED
Unravelling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
The Netherlands Asthma Foundation
Conditions:
Asthma
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Approximately 5% of asthma patients suffer from severe asthma that is characterized by frequent asthma exacerbations resulting in significant morbidity and excessive utilisation of health care resourc...
Detailed Description
This study has a two-fold purpose: 1. to unravel the targets of BT in severe asthma (how does it work?) which is fundamental for better patient selection (who benefits most?) and further improvement ...
Eligibility Criteria
Inclusion
- Males or females age 18 or greater and 65 or less
- The diagnosis of asthma confirmed by at least one of the following as assessed at least once during the past 5 years before the study:
- Reversibility to β2-agonists ≥12% predicted and ≥200ml after 400μg inhaled salbutamol or equivalent
- Bronchial hyper-responsiveness to methacholine or histamine
- Peak-flow variability of \>20% over a period of 14 days
- Fall in FEV1 \>12% and \>200ml when tapering treatment (ICS, oral steroid, LABA and/or LTRA).
- Subject is taking regular maintenance medication (GINA step 4-5) for past 6 months that includes:
- Inhaled corticosteroid at a dosage ≥500μg fluticasone equivalent per day AND
- Long acting ß2-agonist at a dosage of ≥100μg per day salmeterol dose aerosol or equivalent).
- Per protocol bronchial hyper-responsiveness to methacholine (PC20\<4 mg/ml)
- Other asthma medications are acceptable (such as Leukotriene modifiers, Theophylline, Omalizumab treatment (or discontinuation for at least 6 months) Systemic corticosteroid use (≤20mg/day prednisone equivalent))
- Pre-bronchodilator FEV1 ≥50% predicted (stabilized on ICS/LABA) and post-bronchodilator FEV1 ≥60%
- ACQ \>1,5 for 2 weeks
- Non-smoker for 1 year or more (former smoker ≤15 pack years)
- Ability to undergo bronchoscopy and BT in the opinion of the investigator.
- Ability and willingness to provide informed consent.
- For women of childbearing potential: non pregnant, non-lactating, and agree to practice an adequate birth control method for the duration of the study.
Exclusion
- Asthma exacerbation during the prior 4 weeks.
- Subject has 5 or more hospitalizations for exacerbations of asthma in the previous year or 1 or more ICU admission for mechanical or endotracheal intubation for asthma in the previous year.
- Respiratory tract infection within past 4 weeks
- Subject has a known sensitivity to medications required to perform bronchoscopy
- Subject is using immunosuppressant therapy other than oral steroid therapy
- Subject is on anticoagulant medication including anti-platelet agents.
- Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR \>1.5).
- Subject has other respiratory diseases including interstitial lung disease, emphysema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (total IgE of \>1000 Units/mL with positive specific IgE to aspergillus and evidence of central bronchiectasis).
- Subject has segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate, or pneumothorax, confirmed on x-ray. Bronchiectasis on HR-CT-of the chest, both centrally or peripherally will be excluded.
- Subject has clinically significant cardiovascular disease, including myocardial infarction, angina, cardiac dysrhythmia, conduction defect, cardiomyopathy, aortic aneurysm, or stroke at the discretion of the investigator
- Subject has uncontrolled hypertension (\>200mmHg systolic or \>100mmHg diastolic pressure).
- Subject uses an internal or external pacemaker or cardiac defibrillator.
- Other chronic diseases that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. liver, kidney, or nervous system
- Current smokers, and a history of cigarette smoking with \>15 pack years total
- Use of investigative drugs or intervention trials in the 4 months prior to enrolment or during the duration of the study
- Any condition or compliance issue which in the opinion of the investigator might interfere with participation inthe study
- BMI \>35
- Pre-bronchodilator FEV1 \<1.2L
- Extreme coughing
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02225392
Start Date
April 1 2014
End Date
December 1 2019
Last Update
December 5 2022
Active Locations (3)
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1
Academisch Medisch Centrum
Amsterdam, North Holland, Netherlands, 1105 AZ
2
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
3
Royal Brompton Hospital
London, United Kingdom, SW3 6NP