- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02065128
The Efficacy of Capsaicin Sensitivity Testing in Patients With Irritable Larynx Syndrome
Irritable larynx syndrome (ILS) is a hyperkinetic laryngeal dysfunction that is characterized by a persistent cough, voice changes, or breathing difficulties, which are often triggered by an irritant. Diagnosis of ILS is difficult and typically made via a thorough review of the clinical history and, occasionally, the patient's reaction to an odor-provocation test. Standard treatment for ILS is behavioural therapy with a speech language pathologist (SLP), which provides symptom improvement for most patients. However, currently, there are no objective measures of the upper airway hyper-responsiveness in this condition to assist in diagnosing and monitoring disease severity.
Since the cough is irritant-based, it is anticipated that patients with ILS will have a hypersensitivity to the irritant capsaicin. Capsaicin is the active component of chili peppers and is what makes them hot. The capsaicin cough challenge is a well recognized test that involves inhaling different concentrations of capsaicin solutions to determine a cough reflex sensitivity.
The purpose of this research study is to confirm that ILS patients have a hypersensitivity to capsaicin compared to healthy volunteers. If a hypersensitivity is observed in ILS patients, the second objective of this study will be to see if behavioural therapy improves the cough reflex sensitivity in this patient population.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
ILS Participants:
Inclusion Criteria:
- Diagnosis of ILS as per the St Michael's voice clinic consultation
- Methacholine test performed
- Negative/borderline result for methacholine test and/or negative/incomplete response for asthma treatment
- Negative test result for gastroesophageal reflux or negative/incomplete response to reflux treatment
- Allergy test has been completed with negative result or does not account for all symptoms
- Agreed to behavioural therapy in SMH Voice Disorders Clinic
Exclusion Criteria:
- Active smoker
- Active respiratory disease (e.g., COPD, pulmonary fibrosis, lung malignancy.)
- Taking an ACE inhibitor
- Pregnant and/or breastfeeding
- Impaired liver and/or renal function
- Neurological disorder
- Psychiatric condition (outside of depression or anxiety)
Healthy Volunteers:
Exclusion Criteria:
- Active smoker
- Active respiratory disease (e.g. COPD, asthma)
- ILS diagnosis
- Chronic cough diagnosis
- Known hypersensitivity to capsaicin
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
Capsaicin cough challenge test.
The ILS participants will be asked to attend two study visits at the pulmonary function laboratory at SMH; one before behavioural therapy and one after.
The healthy volunteers will be asked to attend one study visit.
At each of these study visits, the ILS participants will complete the Leicester Cough Questionnaire (LCQ) (Appendix B) and the Dyspnea Index (DI) Questionnaire (Appendix C).
The LCQ is a valid assessment tool for evaluating the impact of cough on QoL.19
The DI is a short, validated questionnaire used to quantify a patient's symptoms of dyspnea.20
Following completion of the questionnaires, participants will complete a capsaicin cough challenge test, which is discussed in the following section.
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The capsaicin cough challenge testing will be conducted in the pulmonary function laboratory at SMH by a pulmonary function technologist.
The test involves having the participant inhale increasing concentrations of capsaicin solutions and assessing their response.
The tidal breathing method and solution preparation presented by Nejla, et al. 12 will be used to conduct this testing.
The tidal breathing method is preferred to the alternative dosimeter method as it produces similar results with lower capsaicin concentrations thereby resulting in less throat irritation for the participant.
The technique is detailed in the following sections.
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Irritable Larynx Syndrome Patients
Capsaicin cough challenge test.
The ILS participants will be asked to attend two study visits at the pulmonary function laboratory at SMH; one before behavioural therapy and one after.
The healthy volunteers will be asked to attend one study visit.
At each of these study visits, the ILS participants will complete the Leicester Cough Questionnaire (LCQ) (Appendix B) and the Dyspnea Index (DI) Questionnaire (Appendix C).
The LCQ is a valid assessment tool for evaluating the impact of cough on QoL.19
The DI is a short, validated questionnaire used to quantify a patient's symptoms of dyspnea.20
Following completion of the questionnaires, participants will complete a capsaicin cough challenge test, which is discussed in the following section.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cough reflex sensitivity
Time Frame: measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers
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measured via the capsaicin cough challenge test
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measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer Anderson, MD, FRCS(C), Chief, Department of Otolaryngology - Head and Neck Surgery
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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