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Completed

NCT Number: NCT01928901

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

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

Completed

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Key information

Conditions

Current Smokers

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers who have given their signed declaration of consent and have signed the data protection declaration
  • Male or female volunteers 25 - 40 years
  • Current smokers (5-20 cigarettes per day since 5 years at least)
  • Ability to taste sweetness of saccharin
  • Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve

Exclusion criteria

  • Ciliary dyskinesia
  • Cystic fibrosis
  • COPD/emphysema
  • Asthma
  • Chronic rhinosinusitis
  • Acute respiratory tract infection within the last 6 weeks prior to enrolment
  • Septal or sinus surgery
  • Symptomatic allergic rhinitis
  • Known allergic rhinitis
  • Treatment with not-permitted previous or concomitant therapy
  • 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
  • Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement

Treatment and study plan

administration of Sinupret

Drug

administration of Bronchipret

Drug

administration of Sinupret Placebo

Drug

administration of Bronchipret Placebo

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bionorica SE

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Aug 27, 2013
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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