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

Phase 2

Completed

• Conditions: Current Smokers
• Interventions: Drug: administration of Bronchipret; Drug: administration of Sinupret; Drug: administration of Bronchipret Placebo; Drug: administration of Sinupret Placebo

• Registration Number: NCT01928901
• Lead Sponsor: Bionorica SE

Brief Summary

Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-27
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
administration of Bronchipret	administration of Bronchipret	7 days of administration of Bronchipret, 2 FCT t.i.d
administration of Bronchipret	administration of Bronchipret Placebo	7 days of administration of Bronchipret, 2 FCT t.i.d
administration of Sinupret	administration of Sinupret	7 days of administration of Sinupret, 2 CT t.i.d
administration of Sinupret	administration of Sinupret Placebo	7 days of administration of Sinupret, 2 CT t.i.d
administration of Bronchipret Placebo	administration of Bronchipret	7 days of administration of Bronchipret Placebo, 2 FCT t.i.d
administration of Bronchipret Placebo	administration of Bronchipret Placebo	7 days of administration of Bronchipret Placebo, 2 FCT t.i.d
administration of Sinupret Placebo	administration of Sinupret	7 days of administration of Sinupret Placebo, 2 CT t.i.d
administration of Sinupret Placebo	administration of Sinupret Placebo	7 days of administration of Sinupret Placebo, 2 CT t.i.d

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium