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Trial record 50 of 248 for:    test AND provocation

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

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ClinicalTrials.gov Identifier: NCT02065128
Recruitment Status : Withdrawn (Logistical challenges with research pharmacy prevented the dilution of the capsaicin. No participants were ever recruited, enrolled, or approached.)
First Posted : February 17, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment
Cough Larynx Other: Capsaicin cough challenge test

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Efficacy of Capsaicin Sensitivity Testing in Patients With Irritable Larynx Syndrome
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

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

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.
Other: 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.

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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ILS Patients
Criteria

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

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): NCT02065128


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Jennifer Anderson, MD, FRCS(C) Chief, Department of Otolaryngology - Head and Neck Surgery

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02065128     History of Changes
Other Study ID Numbers: 14-005
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs