Back to resultsThe Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Primary Purpose
Chronic Cough
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
capsaicin challenge
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Cough focused on measuring chronic cough, cough reflex hypersensitivity, capsaicin
Eligibility Criteria
Inclusion Criteria:
- Patients with persisting cough for more than 3 months, without known respiratory or lung diseases
Exclusion Criteria:
- Diagnosis of respiratory or lung diseases of any kind
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
chronic cough
Arm Description
Capsaicine challenge in chronic cough patients
Outcomes
Primary Outcome Measures
cough reflex hypersensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT01807832
First Posted
March 7, 2013
Last Updated
March 7, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01807832
Brief Title
The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Official Title
The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the capsaicin challenge can improve the diagnosis, treatment, monitoring and follow-up in patients with chronic cough.
Detailed Description
Capsaicin is administrated in incremental concentrations with two inhalations of normal saline solution. Patients are instructed to exhale to functional residual capacity and than to inhale through the mouthpiece for 1 second (single breath inhalation). The number of coughs in the first 10 seconds after each inhalation is counted. C2; the concentration of which the patient responded by 2 coughs, C5;the concentration of which the patient responded by 5 coughs. The challenge ends at C5.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough
Keywords
chronic cough, cough reflex hypersensitivity, capsaicin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronic cough
Arm Type
Other
Arm Description
Capsaicine challenge in chronic cough patients
Intervention Type
Other
Intervention Name(s)
capsaicin challenge
Primary Outcome Measure Information:
Title
cough reflex hypersensitivity
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with persisting cough for more than 3 months, without known respiratory or lung diseases
Exclusion Criteria:
Diagnosis of respiratory or lung diseases of any kind
12. IPD Sharing Statement
Learn more about this trial
The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
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