Influence on Cough and Airway Symptoms by Oral Capsaicin

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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 cough reflex and improve unexplained coughing.

Study period

• Estimated Start date (first patient enrolled) June 2019

• Estimated End date (last patient completed follow up) June 2020

• First data available for presentation September 2020

Investigational product/comparator

The formulation is prepared from Capsicum oleoresin. Each capsule will contend a dose corresponding to 0.4 mg capsaicin. All test methods are as per the European Pharmacopoeia for Capsicum oleoresin refined and standardised.

• The formulation is developed by Research Institutes of Sweden (RISE), Sodertalje, Sweden

• Supplier of raw material for the Capsicum oleoresin product/IMP: RANSOM; Ltd, London, UK

• Producer of capsules with Capsicum oleoresin and placebo: by Catalent Pharma Solutions, St Petersburg, Florida, USA

• Packing bottles of capsules with the investigational medical product (IMP) and placebo:

by Apotek Produktion & Laboratorier AB (APL), Stockholm, Sweden

Study design

Capsules, taken orally, with standardised doses of Capsicum oleoresin corresponding to 0.4 mg pure capsaicin (from chili extract) in each capsule in comparison to matched capsules with placebo (sorbitol and colorant), all capsules looking the same. Four weeks of active treatment is compared to four weeks of placebo. In between there is a wash out period of two weeks.

The time frame is 24 hours + 10 weeks. During the first 24 hours the patients carry a cough recorder (Leicester Cough Monitor - LCM) and then start with 4 weeks of active treatment or placebo. This is followed by 2 weeks of wash out and then the patients start with another 4 weeks of active treatment or placebo. After this the study ends.

Collaboration

Professor Alyn Morice MD, PhD, chief physician at Hull York Medical School, University of Hull, UK. Professor Surinder Birring MD, Senior Lecturer, specialist in respiratory medicine, Imperial College, London, UK. Associate professor Alastair Ross,PhD, Chalmers University of Technology, Gothenburg, Sweden.

Study center and number of subjects planned

All clinical trials take place at the asthma and allergy clinic, Sahlgrenska University Hospital, Gothenburg, Sweden from where 60 patients with chronic idiopathic cough (CIC) are recruited.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vastra Gotaland Region
• Collaborators: Sahlgrenska University Hospital, Sweden; Vinnova
• Treatments: Capsaicin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.