Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01807832
Recruitment Status : Unknown
Verified March 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE March 7, 2013
First Posted Date  ICMJE March 8, 2013
Last Update Posted Date March 8, 2013
Study Start Date  ICMJE March 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
cough reflex hypersensitivity [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
Official Title  ICMJE The Use of Capsaicin Challenge for Diagnosis, Monitoring and Follow-up of Chronic Cough.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Cough
Intervention  ICMJE Other: capsaicin challenge
Study Arms  ICMJE chronic cough
Capsaicine challenge in chronic cough patients
Intervention: Other: capsaicin challenge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2013)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01807832
Other Study ID Numbers  ICMJE TASMC-13-LF-0695-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tel-Aviv Sourasky Medical Center
Study Sponsor  ICMJE Tel-Aviv Sourasky Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP