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

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ClinicalTrials.gov Identifier: NCT03281941
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ran Wang, National Health Service, United Kingdom

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.

Condition or disease Intervention/treatment Phase
Asthma Chronic, Cough Other: Inhaled capsaicin cough challenge Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ToAST: Investigating the Effect of Bronchial Thermoplasty on Cough in Patients With Severe Asthma
Actual Study Start Date : August 6, 2016
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Cough
Drug Information available for: Capsaicin

Arm Intervention/treatment
Patients without BT Other: Inhaled capsaicin cough challenge
Post BT Other: Inhaled capsaicin cough challenge



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Change in %FEV1 predicted during capsaicin challenge period in all subjects [ Time Frame: Through study completion, an average of 6 months ]
    By measuring spirometry immediately before and after challenge

  2. The tolerability of inhaled capsaicin in severe asthma [ Time Frame: Through study completion, an average of 6 months ]
    By exploring the pattern of termination of challenge in severe asthma

  3. 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 ]
    by follow up phone calls at 48 hours, 3 days and 7 days to assess AE and SAE

  4. Degree of breathlessness during capsaicin challenge period assessed by using modified Borg scale (mBorg). [ Time Frame: Through study completion, an average of 6 months ]
    By calculating Borg immediately before and after challenge to assess level of breathlessness.

  5. 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 ]
    By calculating dVAS immediately before and after challenge to assess level of breathlessness.

  6. 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 ]
    by comparing post-BT and no-BT patients

  7. 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 ]
    by comparing post-BT and no-BT patients

  8. 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 ]
    by comparing post-BT and no-BT patients

  9. 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 ]
    by comparing post-BT and no-BT patients

  10. 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 ]
    By comparing with existing data.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281941


Contacts
Contact: Ran Wang ranwang1986@googlemail.com

Locations
United Kingdom
University hospital of South Manchester Recruiting
Manchester, United Kingdom, M23 9LT
Contact: Ran Wang, Dr    7557761062    ranwang1986@googlemail.com   
Sponsors and Collaborators
National Health Service, United Kingdom

Responsible Party: Ran Wang, Dr Ran Wang (Chief Investigator); Professor Jacky Smith (PI), National Health Service, United Kingdom
ClinicalTrials.gov Identifier: NCT03281941     History of Changes
Other Study ID Numbers: NHSUK
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cough
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs