ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
NCT ID: NCT03281941
Last Updated: 2017-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2016-08-06
2018-02-01
Brief Summary
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Detailed Description
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At the end of visit 1, a cough monitor was attached to the subject to monitor cough frequency for the next 24 hours and this was returned at visit 2.
Visit 2 followed within two weeks after visit 1, during which a full dose capsaicin cough challenge was performed. Emergency contact details were given towards end of visit 2 should any adverse events occur.
Telephone call within 48 hours, Day 3 and Day 7: The purpose of these phone calls was to ensure that the patient had not developed any adverse effects to the capsaicin challenge.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients without BT
Inhaled capsaicin cough challenge
Post BT
Inhaled capsaicin cough challenge
Interventions
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Inhaled capsaicin cough challenge
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Responsible Party
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Ran Wang
Dr Ran Wang (Chief Investigator); Professor Jacky Smith (PI)
Locations
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University hospital of South Manchester
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NHSUK
Identifier Type: -
Identifier Source: org_study_id
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