Current Smokers
Conditions
Brief summary
Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance
Interventions
DRUGadministration of Sinupret
DRUGadministration of Bronchipret
DRUGadministration of Sinupret Placebo
DRUGadministration of Bronchipret Placebo
Sponsors
Bionorica SE
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Volunteers who have given their signed declaration of consent and have signed the data protection declaration 2. Male or female volunteers 25 - 40 years 3. Current smokers (5-20 cigarettes per day since 5 years at least) 4. Ability to taste sweetness of saccharin 5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve
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 | Description |
|---|---|---|
| Time to perception of sweetness | after 7 days of treatment | Time to perception of sweetness after 7 days of treatment with the investigational products - relative to the time to perception of sweetness at the begin-ning of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Sweetness of Saccharin | 4 - 7 weeks | To measure the time to perception of sweetness of Saccharin after 7 days of treatment with the investigational products calculated as difference to time to perception of sweetness at the beginning of treatment. The time of sweetness will be measured in minutes and seconds. |
Countries
Belgium
Outcome results
None listed