CoughNCT02065128
The Efficacy of Capsaicin Sensitivity Testing in Patients With Irritable Larynx Syndrome
An observational study of Cough and Larynx, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Capsaicin cough challenge test
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ILS Patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Capsaicin cough challenge test
- Medical subject headings
- Cough, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin cough challenge testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Capsaicin cough challenge test | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough reflex sensitivity
measured via the capsaicin cough challenge test
Measured: measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study start1 Aug 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Logistical challenges with research pharmacy prevented the dilution of the capsaicin. No participants were ever recruited, enrolled, or approached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Anderson, MD, FRCS(C), Principal investigator, Chief, Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065128
- Sponsor's protocol ID
- 14-005
- Status last verified
- Jul 2017
- First submitted
- 11 Feb 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Capsaicin Sensitivity Testing in Patients With Irritable Larynx Syndrome
- ClinicalTrials.gov ID
- NCT02065128
- Acronym / sponsor ID
- 14-005
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical challenges with research pharmacy prevented the dilution of the capsaicin. No participants were ever recruited, enrolled, or approached.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Capsaicin cough challenge testCapsaicin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ILS Patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin cough challenge testThe 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. | Other | Healthy Volunteers |
Primary outcome
cough reflex sensitivity
Time frame: measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers
measured via the capsaicin cough challenge test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Anderson, MD, FRCS(C) principal investigator
Chief, Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough and Larynx, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough reflex sensitivity (time frame: measured before and after behavioural therapy for ILS participants (approximately 5 month time frame); measured once for healthy volunteers). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017; AzTrials last refreshed its copy on 6 Nov 2026.