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

Randomized, Placebo-controlled, Double-blind, Cross-over 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

Study Overview

• Status: Completed
• Conditions: Current Smokers
• Intervention / Treatment: Drug: administration of Bronchipret; Drug: administration of Bronchipret Placebo; Drug: administration of Sinupret; Drug: administration of Sinupret Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 - 7 weeks

Collaborators and Investigators

• Sponsor: Bionorica SE
• Investigators: Study Chair: Claus Bachert, Prof.Dr.Dr., University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Antifungal Agents; Thymol
• Other Study ID Numbers: Saccharin test