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ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma (ToAST)

Primary Purpose

Asthma Chronic, Cough

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inhaled capsaicin cough challenge
Sponsored by
National Health Service, United Kingdom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma Chronic, Cough

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • University hospital of South ManchesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients without BT

Post BT

Arm Description

Outcomes

Primary Outcome Measures

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
Number of participants who require bronchodilator treatment during capsaicin challenge period
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer

Secondary Outcome Measures

Change in %FEV1 predicted during capsaicin challenge period in all subjects
By measuring spirometry immediately before and after challenge
The tolerability of inhaled capsaicin in severe asthma
By exploring the pattern of termination of challenge in severe asthma
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
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.
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.
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
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
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
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
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.

Full Information

First Posted
August 22, 2017
Last Updated
September 11, 2017
Sponsor
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03281941
Brief Title
ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
Acronym
ToAST
Official Title
ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Anticipated)
Study Completion Date
February 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Service, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Chronic, Cough

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients without BT
Arm Type
Other
Arm Title
Post BT
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Inhaled capsaicin cough challenge
Primary Outcome Measure Information:
Title
Number of participants who has had significant fall in FEV1 (defined as >20%) within the challenge period
Description
By measuring spirometry immediately before and after challenge
Time Frame
Through study completion, an average of 6 months
Title
Number of participants who require bronchodilator treatment during capsaicin challenge period
Description
Defined as rescue medications - 2 puffs of salbutamol inhaler via spacer
Time Frame
Through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Change in %FEV1 predicted during capsaicin challenge period in all subjects
Description
By measuring spirometry immediately before and after challenge
Time Frame
Through study completion, an average of 6 months
Title
The tolerability of inhaled capsaicin in severe asthma
Description
By exploring the pattern of termination of challenge in severe asthma
Time Frame
Through study completion, an average of 6 months
Title
The number of adverse events in all subjects during and after capsaicin evoked cough challenge
Description
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
Title
Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg).
Description
By calculating Borg immediately before and after challenge to assess level of breathlessness.
Time Frame
Through study completion, an average of 6 months
Title
Degree of breathlessness during capsaicin challenge period assessed by using dysnoea Visual Analogue Score (dVAS).
Description
By calculating dVAS immediately before and after challenge to assess level of breathlessness.
Time Frame
Through study completion, an average of 6 months
Title
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
Description
by comparing post-BT and no-BT patients
Time Frame
Through study completion, an average of 6 months
Title
The differences in 24-hour cough frequency between patients who have had BT and those who have not.
Description
by comparing post-BT and no-BT patients
Time Frame
Through study completion, an average of 6 months
Title
The differences in Leicester cough questionnaire (LCQ) between patients who have had BT and those who have not.
Description
by comparing post-BT and no-BT patients
Time Frame
Through study completion, an average of 6 months
Title
The differences in asthma control questionnaire(ACQ) between patients who have had BT and those who have not.
Description
by comparing post-BT and no-BT patients
Time Frame
Through study completion, an average of 6 months
Title
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).
Description
By comparing with existing data.
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Wang
Email
ranwang1986@googlemail.com
Facility Information:
Facility Name
University hospital of South Manchester
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Wang, Dr
Phone
7557761062
Email
ranwang1986@googlemail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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ToAST:Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma

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