Soft gel capsules with placebo: Sorbitol and colorant.

This is a phase 2 clinical study in humans for therapeutic use of Capsicum oleoresin - (capsaicin) in CIC. The study has a randomised, double-blind and cross-over design. During 4 weeks the participants take either active capsules (Capsicum oleoresin), or matching placebo capsules. This period follows by 2 weeks of "wash out" and then another 4 weeks with active capsules or placebo in accordance with the trial profile below.

Cough

The soft gel capsules used in the study are easily digested in the stomach and contain standardised doses of 0,4 mg Capsicum oleoresin with the main component capsaicin (8-methyl-N-vanillyl-6-nonenamide) (from chili extract).

Capsicum Oleoresin

Soft gel capsules filled with placebo - sorbitol and colorant.

Placebos

Allergy clinic, Sahlgrenska University Hospital

Influence on Cough and Airway Symptoms by Oral Capsaicin

Influence on Cough and Airway Symptoms by Oral Capsaicin - a Phase 2, Randomised, Placebo-controlled Clinical Study in Patients With Chronic Idiopathic Cough

The primary efficacy variables will be capsaicin inhalation cough sensitivity at each visit in terms of:
LogC2 (logarithmic values of the inhaled capsaicin threshold concentration needed to reach two coughs (C2)). Change from baseline at the end of two and four weeks of treatment with active substance or placebo
LogC5 (logarithmic values of the inhaled capsaicin threshold concentration needed to reach five coughs (C5)). Change from baseline at the end of two and four weeks of treatment with active substance or placebo

Objectively measured cough counting (LCM) at four opportunities. Change from baseline at the end of four weeks of treatment with active substance or placebo.

At each visit: Using the VAS-scale evaluating 6 symptoms; cough, rhinitis, throat irritation, dyspnoea, stomach problems and urinary incontinence are recorded on a VAS-scale of 0 to 100 mm, with 0 indicating no symptoms and 100 indicating intense symptoms. The patients put an X on a line of exactly 100 millimeters. The nurse then measures the length from the beginning of the line to the X and register this in the case report form. There are no subscores. The patients are told that an X on the line's beginning indicates no symptoms at all and an X at the line's ending indicates worse possible symptoms.
Change from baseline to each of the four weeks of treatment with active substance and placebo. The procedure takes about 5 minutes. The analyses for all patients will be performed when the entire study is completed.

At study start the patient's height is recorded in meters.

At each visit the patient's weight in kilograms will be recorded.

At each visit the patient's weight in kilograms will be recorded and aggregated with the height measured at baseline to calculate BMI in kg/m2.

At each visit the FEV1 is measured (and predicted values of FEV1 according to gender, age and body length) using the Masterscope spirometer (Masterscope, APS version 5.02 software). After a maximal inhalation a forced exhalation during one second is recorded.

At each visit the predicted values of FEV1 according to gender, age and body length) will be calculated using the Masterscope spirometer (Masterscope, APS version 5.02 software). After a maximal inhalation a forced exhalation during one second is recorded.

At each visit the FVC is measured using the Masterscope spirometer (Masterscope, APS version 5.02 software). The FVC is calculated after maximal inhalation followed by a forced maximal exhalation.

At each visit FEV% is measured. FEV% is defined as FEV1/VC and is thus a measure of how much of her/his vital capacity the patient exhales during the first second of a forced expiration.

At each visit after the spirometry is assessed lung function is also measured with impulse oscillometry (IOS) to record airway resistance at 5 and 20 hertz and to measure the area under the curve (Ax) mirroring the resistance in the peripheral airways using Jaeger Masterscope IOS™. After this the participants inhale bronchodilator medication and 15 minutes thereafter perform an additional lung function test. This is a standard procedure for examining lung function.

At 4 visits lung function is also evaluated with measurements of fractional exhaled nitric oxide (FeNO) in accordance with international American Thoracic Society/ERS recommendations, using a NIOX, nitric oxide gas analyser (Aerocrine AB, Stockholm, Sweden).

At each visit: LogC10 (logarithmic values of the inhaled capsaicin threshold concentration needed to reach 10 coughs) (C10)). Change from baseline at the end of two and four weeks of treatment with active substance or placebo.

At each visit: Evaluating possible chemical changes in the small airways by collecting particles in the exhaled air with a non-invasive method using the PExA 2.0 (PExA AB, Gothenburg, Sweden). After capsaicin provocation and lung function measurements exhaled particles are measured with White FHLC Membrane Filter Type: 0.45mm and then frozen for later analyses.

At each visit: The Hull Airway Reflux Questionnaire (HARQ) was developed with the aim of eliciting the major component of chronic cough in adults. It comprises 14 items with a maximum total score of 70. A Swedish version (HARQ-S) has previously been validated. A total score of <13 points is regarded as normal while higher scores indicate more symptoms and problems of chronic cough.

At each visit: The validated LCQ-S is a self-reporting quality of life measure of chronic cough for adults. It consists of 19 items with a 7-point response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and total score is calculated by adding every domain score.

At each visit: Pain sensitivity is evaluated by pressure pain thresholds for measuring and quantifying deep tenderness in muscles. The Somedic algometer (SBMEDIC Electronics, Solna, Sweden) is a gun-shaped handle creating pressure through a pressure sensitive strain gauge at the tip, connected to a power supply, an amplifier and a display unit. The display shows the actual pressure given (kPa/s), and a scale indicates the rate of pressure to help the examiner to keep the pressure constant.

At each visit: Chest mobility (in cm) is assessed with a tape measure as chest expansion, thoracic flexion and extension. Chest expansion is measured as the circumference difference after maximal inhalation through the nose and maximal exhalation through the mouth at the level of the xiphoid process with participants in a standing position with their hands on their head. Thoracic flexion and thoracic extension are measured 30 cm distally from the seventh cervical vertebrae (C7) in a standing position with the patient's hands along their sides. Every measurement is performed three times, and the best of the three measurements is noted.

At each visits samples are taken for serum analyses with high performance liquid chromatography (HPLC) in accordance with Hartley et al:
"Total capsaicinoids are extracted from 1 mL aliquots of serum or plasma using methyl-isobutyl ketone, evaporation of the extract to dryness and reconstitution with 200 microliter of acetonitrile. The HPLC mobile phase is 40:60 water:acetonitrile. The absorbance of the eluent is monitored at 205 nm. Inter batch reproducibility for both is 15%. The limits of detection are 2.6 and 3.8 ng/mL for capsaicin and dihydrocapsaicin respectively." Also see reference.

Vastra Gotaland Region

Sahlgrenska University Hospital, Sweden

Vinnova

Capsules, taken orally, with standardised doses of Capsicum oleoresin corresponding to 0.4 mg pure capsaicin (from chili extract) in each capsule, will be compared to matched capsules with placebo, all capsules looking the same.

Up to 4 patches to cover a surface of 1200 cm2 will be applied to the painful area depending on the surface of pain during 60 minutes : capsaicin 8% patches (Qutenza)

Up to 4 patches will be applied to the painful area depending on the surface of pain during 60 minutes : placebo

Pain

capsaicin 8% patches (Qutenza)

Placebo patches

Hospital Ambroise Paré, Nutrition Department

Capsaicin Patches In Knee Osteoarthritis In Obese Patients

Efficacy And Safety Of High Concentration Capsaicin Patches In Knee Osteoarthritis In Obese Patients: A Randomized Prospective Double Blind Placebo Controlled Study

The primary outcome measure will be the reduction of average pain intensity as assessed by the patients daily using a pain diary throughout the 3 months of the study. The comparison will be made with baseline pain values started 7 days before the treatment.

dihydrocapsaicin/hypersensibilité

Influence on Cough and Airway Symptoms by Oral Capsaicin

Capsaicin Patches In Knee Osteoarthritis In Obese Patients

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