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Trial record 4 of 11 for:    thymol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928901
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bionorica SE

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

Condition or disease Intervention/treatment Phase
Current Smokers Drug: administration of Sinupret Drug: administration of Bronchipret Drug: administration of Sinupret Placebo Drug: administration of Bronchipret Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Placebo-controlled, Double-blind, Cross-over Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Time to perception of sweetness [ Time Frame: 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 :
  1. Perception of Sweetness of Saccharin [ Time Frame: 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.



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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928901


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
Bionorica SE
Investigators
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Study Chair: Claus Bachert, Prof.Dr.Dr. University Hospital, Ghent

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Responsible Party: Bionorica SE
ClinicalTrials.gov Identifier: NCT01928901     History of Changes
Other Study ID Numbers: Saccharin test
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Thymol
Anti-Infective Agents
Anti-Infective Agents, Local
Antifungal Agents