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Chronic SinusitisPhase 3NCT01706484

Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis

A Phase 3 study testing BNO 1016 in people with Chronic Sinusitis, run by Bionorica SE at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Sinusitis
What is being tested?
BNO 1016
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
927 participants
Where
1 siteBelgium
Study dates
Sep 2012to Jul 2014
Phase
Phase 3
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent including data protection declaration
  • Male and female outpatients aged ≥18 and ≤75 years
  • Diagnosis of bilateral chronic rhinosinusitis without nasal polyps confirmed by:
  • nasal endoscopy during the screening period (nasal endoscopy results not older than 2 month will be accepted) to confirm inflammation, mucopurulent discharge and/or oedema/mucosal obstruction primarily in middle meatus without nasal polyps being present
  • at the discretion of the investigator a historic CT (before screening and not older than 24 months) will be considered additionally for confirmation of bilateral involvement of middle meatus and paranasal sinuses without resolution of symptoms (mucosal changes within the ostiomeatal complex and/or sinuses)
  • Bilateral chronic rhinosinusitis characterized by (V1 and V2):
Show all 9Show fewer
  • presence of chronic rhinosinusitis symptoms for at least 12 weeks without complete resolution of symptoms prior to enrolment (V1)
  • a MSS ≥6 points and ≤12 points for each of the screening days observed by diary entries (MSSPAT)and on the days of Visit 1 and 2 (MSSINV)
  • on 5 random days of the screening period (or at least at days -5 to -1) assessed by MSSPAT and on the day of Visit 1 and 2 assessed by MSSINV: rhinorrhoea (anterior or posterior) and pain (facial pain or headache) of at least moderate intensity (score ≥2).

Who cannot join

  • Sinus surgery within the last 2 years (solitary sinus puncture is allowed)
  • Nasal concha surgery within the last 3 months
  • Presence or history of uni- or bilateral nasal polyps
  • Presence of moderate to severe co-morbid asthma, including allergic asthma
  • Patients with mild asthma having exacerbations within 30 days prior to trial inclusion
  • Patients with cystic fibrosis
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  • Patients with a positive skin prick test at V1 against allergens to which the patient might be exposed to during the expected individual trial duration, if clinically relevant (results not older than 12 months will be accepted)
  • Clinically relevant perennial (e.g. patients with actual clinical symptoms of allergic rhinitis against house dust/-mite antigen) or actual seasonal allergic rhinitis
  • Rhinitis medicamentosa (drug induced rhinitis)
  • Aspirin-Exacerbated Respiratory Disease [AERD] (Aspirin sensitivity)
  • Dentogenic sinusitis or otherwise unilateral sinusitis
  • Presence of anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / airflow
  • Known hypersensitivity to trial medication or excipients
  • Patients with rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency
  • Signs or symptoms of acute bacterial sinusitis (e.g. fever > 38.5°C, orbital complications,severe unilateral frontal headache or toothache)
  • Treatment with systemic or nasal antibiotics or corticosteroids within the last 4 weeks prior to V1
  • Treatment with decongestant preparations (α-sympathomimetics), analgesics (including systemic Non-Steroidal Inflammatory Drugs [NSAIDs], except paracetamol), mucolytics / secretolytics, antihistamines, or alternative medicine preparations for treatment of common cold like symptoms or with immunomodulating properties within the last 7 days prior to V1
  • Patients with gastric or duodenal ulcer
  • Other diseases within 5 years prior to V1, which in the opinion of the investigator disqualifies the patient for trial enrolment (e.g. liver or kidney disease, severe somatopathic, neurological and /or psychiatric diseases, history of malignancy or alcohol or drug abuse or immunodeficiency).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Claus Bachert, Prof. Dr.

    Ghent

Other trials in Belgium

About this study

Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Chronic Rhinosinusitis

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6.

Read the detailed description

The clinical trial population consists of patients presenting with two or more typical symptoms of CRS and duration of symptoms of at least ≥12 weeks. The diagnosis should have been confirmed with the initial diagnosis of CRS by nasal endoscopy and/or computer tomography (CT) and by obligatory nasal endoscopy including exclusion of nasal polyps during screening phase.

A total of 885 patients will be included in this clinical trial, which will last for approximately 12 months, including screening, treatment and medication-free follow-up period as well as final reporting. The duration for the individual patient is approximately 22 weeks (Visit 1 - Visit 7). After a 2-week screening phase, treatment will be started by application of either 240 mg or 480 mg daily dose (t.i.d.) or placebo for 12 weeks followed by a medication-free follow-up period.

Symptoms often do not correlate to the findings in nasal endoscopy or CT. Therefore, efficacy in this clinical trial is defined as per clinical definition using five individual rhinosinusitis symptoms (MSS)graded by the investigator using increasing severity grading(0 = absent [none / not present], 1 = mild, 2 = moderate, 3 = severe).

Secondary outcome measures include

  • single rhinosinusitis symptoms of CRS (MSSINV and MSSPAT),
  • Work Productivity and Activity Impairment patient questionnaire related to General Health [WPAI:GH],
  • total symptom severity by Visual Analogue Scale
  • response to treatment rated by investigator and patient
  • 20-Question Sino-Nasal Outcome Test [SNOT-20, only Germany]
  • percentage of patients with permitted concomitant medication for the treatment of CRS
  • premature termination due to exacerbations of symptoms
  • post treatment course of CRS will
  • pharmacoeconomic assessments
  • safety and tolerability of trial treatment
Being tested
BNO 1016
Keywords
randomized clinical trial, chronic rhinosinusitis, herbal extract BNO 1016, exacerbation, pharmacoeconomic, quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNO 1016Drug

    Also called herbal plant extract,, sinupret extract mite

    comparison of different dosages of drug and placebo

Study groups in NCT01706484
Study groupRoleWhat they receive
80 mg BNO 1016 und placeboExperimental2 tablets (one containing 80 mg BNO 1016 and one placebo) by mouth 3 times daily
Receives: Drug: BNO 1016
160 mg BNO 1016Experimental2 tablets (each containing 80 mg BNO 1016) by mouth 3 times daily
Receives: Drug: BNO 1016
placeboPlacebo comparator2 tablets (each without BNO 1016) by mouth 3 times daily
Receives: Drug: BNO 1016

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average of investigator's Major Symptom Score ratings [score points] at V5 and V6

    The primary efficacy endpoint is defined as the average of investigator's Major Symptom Score ratings [score points] at V5 and V6 (arithmetic mean of 2 ratings).

    Measured: 4 weeks

Secondary outcomes (8)

  1. Patient´s MSS ratings [score points] from V5 to V6

    Arithmetic mean of approximately 28 ratings, Diary data

    Measured: 4 weeks

  2. Investigtor´s MSS ratings [score points] at V3

    CRF data

    Measured: Day 8

  3. Investigator´s MSS ratings [score points] at V4

    CRF data

    Measured: Day 29

  4. Investigtor´s MSS ratings [score points] at V5

    CRF data

    Measured: Day 57

  5. Investigtor´s MSS ratings [score points] at V6

    CRF data

    Measured: Day 85

  6. Investigtor´s MSS ratings [score points] at V7

    CRF data

    Measured: Day 141

  7. Responders based on investigators´ ratings at V2, V3, V4, V5, V6 and V7

    Measured: 20 weeks

  8. Responders based on patients´ ratings at V2, V3, V4, V5, V6 and V7

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionApr 2014
  4. Study completionJul 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01706484
Sponsor's protocol ID
CRS-02
Other IDs
2011-003623-35
Status last verified
Jul 2014
First submitted
4 Sep 2012
Last updated
8 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BNO 1016 in people with Chronic Sinusitis, 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 9 inclusion and 19 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 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Average of investigator's Major Symptom Score ratings [score points] at V5 and V6 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01706484.

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 8 Jul 2014.

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