Status:
ACTIVE_NOT_RECRUITING
Influence on Cough and Airway Symptoms by Oral Capsaicin
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Sahlgrenska University Hospital
Vinnova
Conditions:
Cough
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Study objectives To establish whether an oral intake of Capsicum oleoresin; capsaicinoids expressed as 0.4 mg capsaicin (C18H27N03; Mw: 305.4) in each capsule (from chili extract) can desensitise the...
Detailed Description
This is a phase 2 clinical study in humans for therapeutic use of Capsicum oleoresin - (capsaicin) in chronic idiopathic cough (CIC). The study has a randomised, double-blind and cross-over design. Du...
Eligibility Criteria
Inclusion
- Out-patients, men and women
- Age 18-75 years
- Present non-smoker
- A diagnosis of CIC, set by a trained specialised physician
- Exceeding the cut off limit for the Swedish version of the Hull Airway Reflux Questionnaire (HARQ-S): (a total score of ≥13 points)
- At screening visit reporting daily, troublesome coughing and an easily evoked cough reflex since at least two months
- At screening visit having a positive capsaicin inhalation cough test
Exclusion
- Known or suspected chili allergy
- Known or suspected allergy to the colorant Tartrazine (FD\&C Yellow #6)
- Any kind of diabetes
- Treatment the preceding month with any kind of chili medication or food supplement containing capsaicin or having a diet including chili in treatment purpose
- Treatment the preceding month with medication according to the study protocol
- Pregnancy, breast-feeding, planned pregnancy during the study and fertile women not using acceptable contraceptive measures, as judged by the investigator
- Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficult to read and/or understand Swedish or any other reason, as judged by the investigator
- Airway infection the last 4 weeks before study start
- Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
- Any clinically relevant abnormal findings in physical examination, vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
- Previous randomisation of treatment in the present study
- Participation in another clinical study 30 days prior to and during this study
- Smoking during the last ten years or/and \>10 pack years
- Known alcohol and/or drug abuse
- The participants will be asked for any season allergy or other allergy and for allergen exposure. The study start date will be adjusted to season or another possible allergen exposure.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04125563
Start Date
June 1 2019
End Date
June 15 2026
Last Update
November 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allergy clinic, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden, 413 45