ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Number of participants who require bronchodilator treatment during capsaicin challenge period
研究概览
简要总结
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 symptoms and threshold in patients with and without bronchial thermoplasty.
详细描述
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 (Asthma Control Questionnaires and Leicester Cough Questionnaire, and basic lung physiological assessment were performed.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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.
研究组 & 干预措施
Patients without BT
干预措施: Inhaled capsaicin cough challenge (Other)
Post BT
干预措施: Inhaled capsaicin cough challenge (Other)
结局指标
主要结局
Number of participants who require bronchodilator treatment during capsaicin challenge period
时间窗: Through study completion, an average of 6 months
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period
时间窗: Through study completion, an average of 6 months
By measuring spirometry immediately before and after challenge
次要结局
- Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg).(Through study completion, an average of 6 months)
- Change in %FEV1 predicted during capsaicin challenge period in all subjects(Through study completion, an average of 6 months)
- Degree of breathlessness during capsaicin challenge period assessed by using dysnoea Visual Analogue Score (dVAS).(Through study completion, an average of 6 months)
- The differences in 24-hour cough frequency between patients who have had BT and those who have not.(Through study completion, an average of 6 months)
- The differences in Leicester cough questionnaire (LCQ) between patients who have had BT and those who have not.(Through study completion, an average of 6 months)
- The differences in asthma control questionnaire(ACQ) between patients who have had BT and those who have not.(Through study completion, an average of 6 months)
- The differences of the dose response curves in patients with severe asthma with existing data of capsaicin challenge in patients with healthy and mild/moderate asthma (in Emax and ED50).(Through study completion, an average of 6 months)
- The tolerability of inhaled capsaicin in severe asthma(Through study completion, an average of 6 months)
- The number of adverse events in all subjects during and after capsaicin evoked cough challenge(Through study completion, an average of 6 months)
- Differences in capsaicin dose response curves (Maximum cough response evoked by any concentration of capsaicin- Emax and Capsaicin dose inducing half-maximal response - ED50) between subjects who have had BT versus those have not(Through study completion, an average of 6 months)
研究者
Ran Wang
Dr Ran Wang (Chief Investigator); Professor Jacky Smith (PI)
National Health Service, United Kingdom