The Efficacy of Capsaicin Sensitivity Testing in Patients With Irritable Larynx Syndrome

NCT ID: NCT02065128

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2017-08-31

Brief Summary

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.

Detailed Description

The proposed study has two purposes; the first is to utilize capsaicin cough challenge to demonstrate an increased efferent receptor sensitivity level in ILS subjects as compared to a control group. The second is to determine if there is an objective change in capsaicin cough challenge results after behavioral therapy, and whether it correlates to the subjective improvement. Self-reporting measures include two validated cough quality of life (QoL) questionnaires collected at the same intervals as the capsaicin testing.

Conditions

Cough; Larynx

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Capsaicin cough challenge test

Intervention Type: OTHER

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.

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.

No interventions assigned to this group

Interventions

Capsaicin cough challenge test

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.

Intervention Type: OTHER

Eligibility Criteria

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:

• Active smoker
• Active respiratory disease (e.g. COPD, asthma)
• ILS diagnosis
• Chronic cough diagnosis
• Known hypersensitivity to capsaicin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Anderson, MD, FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Chief, Department of Otolaryngology - Head and Neck Surgery

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-005

Identifier Type: -

Identifier Source: org_study_id