Asthma Chronic, CoughToASTNCT03281941
ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
A study testing Inhaled capsaicin cough challenge in people with Asthma Chronic, Cough, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial 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 symptoms and threshold in patients with and without bronchial thermoplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma Chronic, Cough
- What is being tested?
- Inhaled capsaicin cough challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2016to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Show all 11Show fewer
- 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%
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Ran Wang contact
United Kingdom1 site, 1 recruiting
- Recruiting
University hospital of South Manchester
Manchester, M23 9LT
Ran Wang, Dr, 7557761062, ranwang1986@googlemail.com
About this study
Official title: ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
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.
Read the 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 (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.
- Conditions
- Asthma Chronic, Cough
- Being tested
- Inhaled capsaicin cough challenge
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled capsaicin cough challengeOther
| Study group | Role | What they receive |
|---|---|---|
| Patients without BT | Other | Not described Receives: Other: Inhaled capsaicin cough challenge |
| Post BT | Other | Not described Receives: Other: Inhaled capsaicin cough challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Through study completion, an average of 6 months
Secondary outcomes (10)
Change in %FEV1 predicted during capsaicin challenge period in all subjects
By measuring spirometry immediately before and after challenge
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start6 Aug 2016
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma Chronic, CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ran Wang, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281941
- Sponsor's protocol ID
- NHSUK
- Acronym
- ToAST
- Status last verified
- Sep 2017
- First submitted
- 22 Aug 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
- ClinicalTrials.gov ID
- NCT03281941
- Acronym / sponsor ID
- ToAST / NHSUK
- Conditions
- Asthma Chronic, Cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Health Service, United KingdomOther government
- Study start
- 6 Aug 2016 (actual)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without BT | Other | Other: Inhaled capsaicin cough challenge |
| Post BT | Other | Other: Inhaled capsaicin cough challenge |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled capsaicin cough challenge | Other | Patients without BT, Post BT |
Primary outcome
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period
Time frame: Through study completion, an average of 6 months
By measuring spirometry immediately before and after challenge
Number of participants who require bronchodilator treatment during capsaicin challenge period
Time frame: Through study completion, an average of 6 months
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer
10 secondary outcomes
Change in %FEV1 predicted during capsaicin challenge period in all subjects
Time frame: Through study completion, an average of 6 months
The tolerability of inhaled capsaicin 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
Time frame: Through study completion, an average of 6 months
Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg).
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).
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
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.
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.
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.
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).
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled capsaicin cough challenge in people with Asthma Chronic, Cough, run by National Health Service, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Wang (ranwang1986@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.