Status:
UNKNOWN
ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
Lead Sponsor:
National Health Service, United Kingdom
Conditions:
Asthma Chronic, Cough
Eligibility:
All Genders
Phase:
NA
Brief Summary
ToAST study is a pilot study aiming to establish the safety profile of using inhaled capsaicin challenge in patients with severe asthma. The investigators will also explore the differences in cough sy...
Detailed Description
ToAST is designed as a two-visit observational study. During visit 1, written consent and measurements of baseline asthma characteristics were completed; history and examination, questionnaires (Asthm...
Eligibility Criteria
Inclusion
- Aged ≥18
- Person with an established diagnosis of severe asthma
- All patients should be on British Thoracic Society (BTS) steps 4 or 5
- Patients who have had bronchial thermoplasty (BT) should be at least 2 months after their treatment
- Historical evidence of one of the following:
- Airway reversibility to a short acting beta-2 agonist of ≥12%
- Bronchial hyper-responsiveness (PC20\<8mg/ml)
- Fractional exhaled nitric oxide ≥50ppb
- Peak flow variability \>8%
- Raised serum (≥0.45) or sputum eosinophilia (\>3%)
- Variability in spirometry over 24 months of \>20%
Exclusion
- Unable to give informed consent
- FEV1\<50% predicted or \< 1 litre
- Known allergy or intolerance to capsaicin
- Symptoms of upper respiratory tract infection in the last 1 month which have not resolved.
- Lower respiratory tract infection or pneumonia in the last 6 weeks.
- Current smoker or ex-smoker with ≥10 pack year smoking history, abstinence of ≤6 months
- Asthma exacerbation in the previous month requiring an increase or starting of an ICS or OCS
- Subject has changed asthma medication within the past 4 weeks prior to screening
- A previous asthma exacerbation requiring Intensive Care Unit (ICU) admission.
- Significant other pulmonary disorders as the major diagnosis, in particular: pulmonary embolism, pulmonary hypertension, interstitial lung disease, lung cancer, cystic fibrosis, emphysema or bronchiectasis.
- Evidence of vocal cord dysfunction
- Pregnancy or breast-feeding
- Use of ACE inhibitors
- Any centrally acting medication which in the view of the investigator could alter the sensitivity of the cough reflex\*
- History of psychiatric illness, drug or alcohol abuse which may interfere in the participation of the trial.
Key Trial Info
Start Date :
August 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03281941
Start Date
August 6 2016
End Date
February 1 2018
Last Update
September 13 2017
Active Locations (1)
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1
University hospital of South Manchester
Manchester, United Kingdom, M23 9LT