Clinical trial with herbal Bronchipret and Sinupret to evaluate the acceleration of mucociliary clearance ( the self-clearing mechanism of the bronchi)
- Conditions
- PR1: Acceleration of mucociliary clearance as a therapeutic effect when treating inflammation of the nasal sinusesPR2: Acceleration of mucociliary clearance as a therapeutic effect when treating exacerbations of Chronic Obstructive Pulmonary Disease (COPD)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-004864-24-BE
- Lead Sponsor
- Bionorica SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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<br>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<br>Visit 3 (baseline of treatment period 2), safety<br>Visit 4 (end of treatment period 2), effectiveness and safety<br>and 5 (end of follow-up period), safety