Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Logistical challenges with research pharmacy prevented the dilution of the capsaicin. No participants were ever recruited, enrolled, or approached.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin cough challenge test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| cough reflex sensitivity | measured via the capsaicin cough challenge test | measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers |
Not provided
Not provided
ILS Participants:
Inclusion Criteria:
Exclusion Criteria:
Healthy Volunteers:
Exclusion Criteria:
Not provided
Not provided
Not provided
ILS Patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Anderson, MD, FRCS(C) | Chief, Department of Otolaryngology - Head and Neck Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
Not provided
| ID | Term |
|---|---|
| D003371 | Cough |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010038 | Otorhinolaryngologic Diseases |