PR1: Acceleration of mucociliary clearance as a therapeutic effect when treating inflammation of the nasal sinuses PR2: Acceleration of mucociliary clearance as a therapeutic effect when treating exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: Sinupret® extract mite
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use
Trade Name: Bronchipret® TP F
Sponsors
Bionorica SE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers 25 - 40 years (females being non-pregnant/non-breast-feeding and applying a safe method of contraception) 3. Current smokers (5-20 cigarettes per day since at least 5 years for a maximum of 20 years) 4. Ability to taste sweetness of saccharin 5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve 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 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Ciliary dyskinesia 2. Cystic fibrosis 3. COPD/emphysema 4. Asthma 5. Chronic rhinosinusitis 6. Acute respiratory tract infection within the last 6 weeks prior to enrolment 7. Septal or sinus surgery 8. Symptomatic allergic rhinitis 9. Known allergic rhinitis 10. Treatment with not-permitted previous or concomitant therapy 11. History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month 12. Any disease or condition that might affect the safety of the subject during the trial, according to the investigator’s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Proof of concept: Superiority of PR1 or PR2 to PL1 or PL2 regarding acceleration of mucociliary clearance;Secondary Objective: Not applicable;Primary end point(s): Time to perception of sweetness after 7 days (+/- 1 day) of treatment with the investigational products - relative to the time to perception of sweetness at the beginning of treatment;Timepoint(s) of evaluation of this end point: At visits 2 (end of treatment period 1) and 4 (end of treatment period 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to perception of sweetness after 7 days (+/- 1 day) of treatment with the investigational products – calculated as difference to time to perception of sweetness at the beginning of treatment 2. Safety of intake of Bronchipret and Sinupret;Timepoint(s) of evaluation of this end point: Visit 2 (end of treatment period 1), effectiveness and safety Visit 3 (baseline of treatment period 2), safety Visit 4 (end of treatment period 2), effectiveness and safety and 5 (end of follow-up period), safety | — |
Countries
Belgium
Contacts
Public ContactSenior Clinical Research Manager
Cliniresearch BVBA
Outcome results
None listed