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

NCT01928901 | Completed Phase 2

• 1 other identifier: Saccharin test
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Current Smokers

Outcome Measures

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

  after 7 days of treatment

Secondary Outcomes (1)

• Perception of Sweetness of Saccharin

  4 - 7 weeks

Study Arms (4)

administration of Bronchipret

EXPERIMENTAL

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

Drug: administration of Bronchipret; Drug: administration of Bronchipret Placebo

administration of Sinupret

EXPERIMENTAL

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

Drug: administration of Sinupret; Drug: administration of Sinupret Placebo

administration of Bronchipret Placebo

PLACEBO COMPARATOR

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

Drug: administration of Bronchipret; Drug: administration of Bronchipret Placebo

administration of Sinupret Placebo

PLACEBO COMPARATOR

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

Drug: administration of Sinupret; Drug: administration of Sinupret Placebo

Interventions

administration of Sinupret DRUG

administration of Sinupret; administration of Sinupret Placebo

administration of Bronchipret DRUG

administration of Bronchipret; administration of Bronchipret Placebo

administration of Sinupret Placebo DRUG

administration of Sinupret; administration of Sinupret Placebo

administration of Bronchipret Placebo DRUG

administration of Bronchipret; administration of Bronchipret Placebo

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (1)

University Hospital Ghent

Ghent, Ghent, 9000, Belgium

Location

Study Officials

• Claus Bachert, Prof.Dr.Dr.

  University Hospital, Ghent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 27, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

BE (1)