Chronic idiopathic cough
Conditions
Interventions
Product Name: Capsicum oleoresin
Pharmaceutical Form: Capsule
INN or Proposed INN: Capsicum oleoresin
CAS Number: 8023-77-6
Current Sponsor code: evami2
Other descriptive name: CAPSAICIN
Concentrati
Sponsors
Sahlgrenska University Hospital, Department of Internal Medicine/Respiratory Medicine and Allergology
University of Gothenburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Out-patients, men and women • Age 18-75 years • Non-smoker • At screening visit reporting daily, troublesome coughing and an easily evoked cough reflex since at least two months • 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Known or suspected chili allergy • Known or suspected Tartrazine allergy • 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 angiotensin-converting-enzyme (ACE) inhibitors other medications the may influence cough and the cough reflex sensitivity • Treatment the preceding month with morphine or codeine • Treatment the preceding month with Gabepentin or Pregabalin • Treatment the preceding month with insulin • 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 10 pack years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether an oral intake of capsicum oleoresin; capsaicinoids expressed as 0,4 mg capsaicin (C18H27N03; M, 305.4) (from chili extract) can desensitise the cough reflex and improve unexplained coughing.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy variables will be C2log and C5log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach two coughs (C2) and five coughs (C5) at the end of four weeks of treatment;Timepoint(s) of evaluation of this end point: After 4 weeks treatment with either Capsicum oleoresin or placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Objectively measured cough counting (LCM) during 24 hours at four opportunities -Variables C10log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach ten coughs (C10) after 4 weeks treatment -HARQ-S questionnaire after 2 and 4 weeks treatment -LCQ-S questionnaire after 2 and 4 weeks treatment -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms each day: Mean will be calculated for each of the four weeks of treatment. -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms, change from baseline to each of the four weeks of treatment;Timepoint(s) of evaluation of this end point: -Objectively measured cough counting (LCM) during 24 hours at four opportunities: before and after treatment with either active substance or placebo -Variables C10log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach ten coughs (C10) after 2 and 4 weeks treatment -HARQ-S questionnaire and LCQ-S questionnaire after 2 and 4 weeks treatment -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms each day: Mean will be calculated for each of the four weeks of treatment. -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms, change from baseline to each of the four weeks of treatment | — |
Countries
Sweden
Contacts
Public ContactEva Millqvist
Sahlgrenska University Hospital, Department of Internal Medicine, respiratory Medicine and Allergology
Outcome results
None listed