An interventional study of Inhaled capsaicin cough challenge in Asthma Chronic, Cough, sponsored by National Health Service, United Kingdom. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by National Health Service, United Kingdom · Not applicable, Interventional, and Other
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.
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 24 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →National Health Service, United Kingdom is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Inhaled capsaicin cough challenge
Other: Inhaled capsaicin cough challenge
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period
By measuring spirometry immediately before and after challenge
Time frame: Through study completion, an average of 6 months
Number of participants who require bronchodilator treatment during capsaicin challenge period
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer
Time frame: Through study completion, an average of 6 months
Change in %FEV1 predicted during capsaicin challenge period in all subjects
By measuring spirometry immediately before and after challenge
Time frame: Through study completion, an average of 6 months
The tolerability of inhaled capsaicin in severe asthma
By exploring the pattern of termination of challenge in severe asthma
Time frame: Through study completion, an average of 6 months
The number of adverse events in all subjects during and after capsaicin evoked cough challenge
by follow up phone calls at 48 hours, 3 days and 7 days to assess AE and SAE
Time frame: Through study completion, an average of 6 months
Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg).
By calculating Borg immediately before and after challenge to assess level of breathlessness.
Time frame: Through study completion, an average of 6 months
Degree of breathlessness during capsaicin challenge period assessed by using dysnoea Visual Analogue Score (dVAS).
By calculating dVAS immediately before and after challenge to assess level of breathlessness.
Time frame: 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
by comparing post-BT and no-BT patients
Time frame: 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.
by comparing post-BT and no-BT patients
Time frame: 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.
by comparing post-BT and no-BT patients
Time frame: 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.
by comparing post-BT and no-BT patients
Time frame: 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).
By comparing with existing data.
Time frame: Through study completion, an average of 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2016 (actual). Primary completion is estimated for Feb 2018, 17 months after the start.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 17 months is above that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Health Service, United Kingdom