Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
NCT ID: NCT01928901
Last Updated: 2014-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2013-08-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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administration of Bronchipret
7 days of administration of Bronchipret, 2 FCT t.i.d
administration of Bronchipret
administration of Bronchipret Placebo
administration of Sinupret
7 days of administration of Sinupret, 2 CT t.i.d
administration of Sinupret
administration of Sinupret Placebo
administration of Bronchipret Placebo
7 days of administration of Bronchipret Placebo, 2 FCT t.i.d
administration of Bronchipret
administration of Bronchipret Placebo
administration of Sinupret Placebo
7 days of administration of Sinupret Placebo, 2 CT t.i.d
administration of Sinupret
administration of Sinupret Placebo
Interventions
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administration of Sinupret
administration of Bronchipret
administration of Sinupret Placebo
administration of Bronchipret Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
25 Years
40 Years
ALL
Yes
Sponsors
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Bionorica SE
INDUSTRY
Responsible Party
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Principal Investigators
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Claus Bachert, Prof.Dr.Dr.
Role: STUDY_CHAIR
University Hospital, Ghent
Locations
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University Hospital Ghent
Ghent, Ghent, Belgium
Countries
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Other Identifiers
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Saccharin test
Identifier Type: -
Identifier Source: org_study_id
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