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

NCT ID: NCT01928901

Last Updated: 2014-07-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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Conditions

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Current Smokers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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administration of Bronchipret

7 days of administration of Bronchipret, 2 FCT t.i.d

Group Type EXPERIMENTAL

administration of Bronchipret

Intervention Type DRUG

administration of Bronchipret Placebo

Intervention Type DRUG

administration of Sinupret

7 days of administration of Sinupret, 2 CT t.i.d

Group Type EXPERIMENTAL

administration of Sinupret

Intervention Type DRUG

administration of Sinupret Placebo

Intervention Type DRUG

administration of Bronchipret Placebo

7 days of administration of Bronchipret Placebo, 2 FCT t.i.d

Group Type PLACEBO_COMPARATOR

administration of Bronchipret

Intervention Type DRUG

administration of Bronchipret Placebo

Intervention Type DRUG

administration of Sinupret Placebo

7 days of administration of Sinupret Placebo, 2 CT t.i.d

Group Type PLACEBO_COMPARATOR

administration of Sinupret

Intervention Type DRUG

administration of Sinupret Placebo

Intervention Type DRUG

Interventions

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administration of Sinupret

Intervention Type DRUG

administration of Bronchipret

Intervention Type DRUG

administration of Sinupret Placebo

Intervention Type DRUG

administration of Bronchipret Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bionorica SE

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Belgium

Other Identifiers

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Saccharin test

Identifier Type: -

Identifier Source: org_study_id

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