Current SmokersPhase 2NCT01928901
Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
A Phase 2 study testing administration of Sinupret and administration of Bronchipret in people with Current Smokers, run by Bionorica SE at 1 site in Belgium.
Trial summary
Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Current Smokers
- What is being tested?
- administration of Sinupret and administration of Bronchipret
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Ciliary dyskinesia
- Cystic fibrosis
- COPD/emphysema
- Asthma
- Chronic rhinosinusitis
- Acute respiratory tract infection within the last 6 weeks prior to enrolment
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Current Smokers
- Being tested
- administration of Sinupret, administration of Bronchipret, administration of Sinupret Placebo, administration of Bronchipret Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of SinupretDrug
administration of BronchipretDrug
administration of Sinupret PlaceboDrug
administration of Bronchipret PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| administration of Bronchipret | Experimental | 7 days of administration of Bronchipret, 2 FCT t.i.d Receives: Drug: administration of Bronchipret; Drug: administration of Bronchipret Placebo |
| administration of Sinupret | Experimental | 7 days of administration of Sinupret, 2 CT t.i.d Receives: 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 Receives: 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 Receives: Drug: administration of Sinupret; Drug: administration of Sinupret Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 - 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionorica SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Bachert, Prof.Dr.Dr., Study chair, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928901
- Sponsor's protocol ID
- Saccharin test
- Status last verified
- Jun 2014
- First submitted
- 14 Aug 2013
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind, Cross-over Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
- ClinicalTrials.gov ID
- NCT01928901
- Acronym / sponsor ID
- Saccharin test
- Conditions
- Current Smokers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bionorica SEIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| administration of Bronchipret | Experimental | Drug: administration of Bronchipret, Drug: administration of Bronchipret Placebo7 days of administration of Bronchipret, 2 FCT t.i.d |
| administration of Sinupret | Experimental | Drug: administration of Sinupret, Drug: administration of Sinupret Placebo7 days of administration of Sinupret, 2 CT t.i.d |
| administration of Bronchipret Placebo | Placebo comparator | Drug: administration of Bronchipret, Drug: administration of Bronchipret Placebo7 days of administration of Bronchipret Placebo, 2 FCT t.i.d |
| administration of Sinupret Placebo | Placebo comparator | Drug: administration of Sinupret, Drug: administration of Sinupret Placebo7 days of administration of Sinupret Placebo, 2 CT t.i.d |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Ciliary dyskinesia
- Cystic fibrosis
- COPD/emphysema
- Asthma
- Chronic rhinosinusitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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
1 secondary outcome
Perception of Sweetness of Saccharin
Time frame: 4 - 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Bachert, Prof.Dr.Dr. study chair
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing administration of Sinupret and administration of Bronchipret in people with Current Smokers, run by Bionorica SE at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to perception of sweetness (time frame: after 7 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.