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

Current Smokers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01928901
• Other study ID #: Saccharin test
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2013
• Last updated: June 30, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Bionorica SE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Current Smokers

Intervention

Drug:
• administration of Sinupret

• administration of Bronchipret

• administration of Sinupret Placebo

• administration of Bronchipret Placebo

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Bionorica SE

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No