Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)

Study Overview
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Brief Summary
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Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance

Official Title
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Randomized, Placebo-controlled, Double-blind, Cross-over Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)

Conditions
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Current Smokers

Intervention / Treatment
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* Drug: administration of Sinupret
* Drug: administration of Bronchipret
* Drug: administration of Sinupret Placebo
* Drug: administration of Bronchipret Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers who have given their signed declaration of consent and have signed the data protection declaration Male or female volunteers 25 - 40 years Current smokers (5-20 cigarettes per day since 5 years at least) Ability to taste sweetness of saccharin Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve Exclusion Criteria: Ciliary dyskinesia Cystic fibrosis COPD/emphysema Asthma Chronic rhinosinusitis Acute respiratory tract infection within the last 6 weeks prior to enrolment Septal or sinus surgery Symptomatic allergic rhinitis Known allergic rhinitis Treatment with not-permitted previous or concomitant therapy 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 Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: administration of Bronchipret<br>7 days of administration of Bronchipret, 2 FCT t.i.d | Drug: administration of Bronchipret<br> <br> Drug: administration of Bronchipret Placebo<br> <br> |
| Experimental: administration of Sinupret<br>7 days of administration of Sinupret, 2 CT t.i.d | Drug: administration of Sinupret<br> <br> Drug: administration of Sinupret Placebo<br> <br> |
| Placebo Comparator: administration of Bronchipret Placebo<br>7 days of administration of Bronchipret Placebo, 2 FCT t.i.d | Drug: administration of Bronchipret<br> <br> Drug: administration of Bronchipret Placebo<br> <br> |
| Placebo Comparator: administration of Sinupret Placebo<br>7 days of administration of Sinupret Placebo, 2 CT t.i.d | Drug: administration of Sinupret<br> <br> Drug: administration of Sinupret Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perception of sweetness | 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 | after 7 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of Sweetness of Saccharin | 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. | 4 - 7 weeks |