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CompletedNCT01928901Updated Jul 1, 2014

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

A Phase 2 interventional study of administration of Sinupret and administration of Bronchipret in Current Smokers, sponsored by Bionorica SE. Completed at 1 site in Belgium. Open to participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-01.

Sponsored by Bionorica SE · Phase 2, Interventional, and Basic science

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
25 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Current Smokers
03

In context

Lead sponsor

Bionorica SE is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    administration of Bronchipret

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

    Drug: administration of Bronchipret · Drug: administration of Bronchipret Placebo

  • Experimental
    administration of Sinupret

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

    Drug: administration of Sinupret · Drug: administration of Sinupret Placebo

  • Placebo comparator
    administration of Bronchipret Placebo

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

    Drug: administration of Bronchipret · Drug: administration of Bronchipret Placebo

  • Placebo comparator
    administration of Sinupret Placebo

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

    Drug: administration of Sinupret · Drug: administration of Sinupret Placebo

Interventions

  • Drugadministration of Sinupret
  • Drugadministration of Bronchipret
  • Drugadministration of Sinupret Placebo
  • Drugadministration of Bronchipret Placebo
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: after 7 days of treatment

Secondary outcomes

  1. 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.

    Time frame: 4 - 7 weeks

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01928901
Lead sponsor
Bionorica SE
Responsible party
Sponsor
First posted
Aug 27, 2013
Start date
Aug 2013
Primary completion
Dec 2013
Completion
Feb 2014
Last update
Jul 1, 2014

Study contacts

Claus Bachert, Prof.Dr.Dr.
study chair · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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