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Chronic RhinosinusitisPhase 3NCT02746042

Sinupret Extract Coated Tablets in Chronic Rhinosinusitis

A Phase 3 study testing Sinupret extract coated tablets in people with Chronic Rhinosinusitis, run by Bionorica SE at 45 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the treatment of chronic rhinosinusitis (CRS) in adults. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Rhinosinusitis
What is being tested?
Sinupret extract coated tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
572 participants
Where
45 sitesin 2 countries
Study dates
28 Apr 2016to 23 Aug 2017
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 (IC) including data protection declaration
  • Male and female outpatients aged ≥18 and ≤75 years
  • Women will be considered for inclusion if they are not pregnant (as confirmed by urine pregnancy test at V1 and V2), not breastfeeding, or if they are surgically sterile (have had a documented bilateral oophorectomy and/or hysterectomy) or if menopause is ensured (at least 12 months without menstrual bleeding). Women of childbearing potential must use a highly effective (failure rate less than 1% per year, i.e. Pearl Index <1) method of contraception 2 weeks prior to trial inclusion and during the screening/treatment period of the clinical trial (e.g. vasectomized partner, sexual abstinence - the lifestyle of the female has to be such that there is complete abstinence from intercourse from 2 weeks prior to the first dose of trial medication until at least 72 hours after treatment - implants, injectables, combined oral contraceptives, or hormonal intrauterine devices).
  • Diagnosis of bilateral CRS without nasal polyps confirmed by:
  • Nasal endoscopy during the screening phase to confirm inflammation, mucopurulent discharge, and/or edema/mucosal obstruction primarily in middle meatus without nasal polyps being present
  • At the discretion of the investigator, results from a historic imaging diagnostic, i.e. computer tomography (CT), digital volume tomography (DVT), or magnetic resonance tomography (MRT) (before screening and not older than 24 months, not taken during acute exacerbation), which 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)
Show all 9Show fewer
  • Bilateral CRS characterized by:
  • Presence of CRS symptoms for >52 weeks prior to enrolment (V1) as documented in the medical file of the patient
  • Major Symptom Score (MSS) ≥10 at V1 and V2 as assessed by the investigator (MSS INV), and rhinorrhea (anterior or posterior) and pain (facial pain or headache) each of at least moderate intensity (score ≥2)

Who cannot join

  • Sinus surgery within the last 2 years (solitary sinus puncture is allowed)
  • Inferior turbinate reduction (by surgery or other methods) within the last 3 months
  • Presence or history of uni- or bilateral nasal polyps
  • Moderate to severe co-morbid asthma, including allergic asthma
  • Cystic fibrosis
  • Perennial (e.g. patients with clinical symptoms of allergic rhinitis against house dust/mite antigen) or seasonal allergic rhinitis
Show all 26Show fewer
  • Rhinitis medicamentosa (drug induced rhinitis)
  • Aspirin-exacerbated respiratory disease (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
  • Rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency, 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 antihistamines within 4 weeks prior to V1
  • Treatment with 2-3.5% hypertonic saline solution within 2 weeks prior to V1
  • Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks prior to V1
  • Treatment with decongestant preparations (α-sympathomimetics), analgesics (including systemic non-steroidal inflammatory drugs [NSAIDs], including paracetamol), mucolytics/secretolytics, or alternative medicine preparations for treatment of common cold-like symptoms or with immunomodulating properties within 7 days prior to V1
  • Peptic ulcer
  • Gastritis
  • Other diseases within 5 years prior to V1 that, 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, alcohol or drug abuse, or immunodeficiency)
  • Parallel participation in another clinical trial, participation in a different trial within less than 6 weeks prior to trial entry, or previous randomization into this clinical trial
  • Known to be, or suspected of being unable to comply with the clinical trial protocol (CTP) that in the opinion of the investigator disqualifies the patient for trial enrolment (e.g. no permanent address, known to be non-compliant, or presenting an unstable psychiatric history)
  • Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the clinical trial
  • Patients in custody by juridical or official order
  • Patients who have difficulties in understanding the local language in which the patient information (PI) is given
  • Patients who are members of the staff of the investigational site, staff of the sponsor or involved CRO, the investigator him/herself or close relatives

Trial locations and contacts

45 sites in 2 countries.

45 sites in 2 countries

Poland23 sites

  • Bionorica Investigative Site

    Bialystok, 15-270

  • Bionorica Investigative Site

    Bialystok, 15-879

  • Bionorica Investigative Site

    Bydgoszcz

  • Bionorica Investigative Site

    Gdansk

  • Bionorica Investigative Site

    Gdynia

  • Bionorica Investigative Site

    Katowice, 40-036

  • Bionorica Investigative Site

    Katowice, 40-611

  • Bionorica Investigative Site

    Katowice, 40-954

  • Bionorica Investigative Site

    Kielce

  • Bionorica Investigative Site

    Krakow, 30-349

  • Bionorica Investigative Site

    Krakow, 30-548

  • Bionorica Investigative Site

    Krakow, 31-624

  • Bionorica Investigative Site

    Limanowa

  • Bionorica Investigative Site

    Lodz

  • Bionorica Investigative Site

    Lublin, 20-552

  • Bionorica Investigative Site

    Piaseczno

  • Bionorica Investigative Site

    Szczecin

  • Bionorica Investigative Site

    Tychy

  • Bionorica Investigative Site

    Warsaw, 01-868

  • Bionorica Investigative Site

    Wieliczka

  • Bionorica Investigative Site

    Wroclaw

  • Bionorica Investigative Site 222

    Zgierz

  • Bionorica Investigative Site 224

    Zgierz

Other trials in Poland

Germany22 sites

  • Bionorica Investigative Site

    Berlin, 13353

  • Bionorica Investigative Site

    Braunschweig

  • Bionorica Investigative Site

    Chemnitz

  • Bionorica Investigative Site

    Dresden, 01067

  • Bionorica Investigative Site

    Dresden, 01139

  • Bionorica Investigative Site

    Dresden, 01159

  • Bionorica Investigative Site

    Dresden, 01307

  • Bionorica Investigative Site

    Duisburg

  • Bionorica Investigative Site

    Essen

  • Bionorica Investigative Site

    Frankfurt am Main

  • Bionorica Investigative Site

    Göttingen

  • Bionorica Investigative Site

    Heidelberg, 69120

  • Bionorica Investigative Site

    Heidelberg, 69126

  • Bionorica Investigative Site

    Markkleeberg

  • Bionorica Investigative Site

    Mittweida

  • Bionorica Investigative Site

    Munich, 80331

  • Bionorica Investigative Site

    Neuenhagen

  • Bionorica Investigative Site

    Nuremberg

  • Bionorica Investigative Site

    Röthenbach/Pegnitz

  • Bionorica Investigative Site

    Schlüchtern

  • Bionorica Investigative Site

    Schorndorf

  • Bionorica Investigative Site

    Wuppertal

Other trials in Germany

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Assess Efficacy and Safety of the Herbal Medicinal Product Sinupret Extract Coated Tablets in Patients With Chronic Rhinosinusitis

To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the treatment of chronic rhinosinusitis (CRS) in adults.

Read the detailed description

The aim of the present double-blind, placebo-controlled, parallel-group, randomized, phase III clinical trial is to assess the efficacy, safety, and tolerability of Sinupret extract (3 x 160 mg = 480 mg daily) taken for up to 16-weeks compared with placebo in the treatment of chronic rhinosinusitis (CRS) in adults. In addition, in an exploratory approach to identify potential pharmacological modes of action underlying the expected treatment benefit, the anti-inflammatory activity of Sinupret extract will be assessed in a subset of CRS patients.

Being tested
Sinupret extract coated tablets, Placebo coated tablets
Keywords
chronic rhinosinusitis, Sinupret extract, herbal medicinal product

What participants receive

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

  • Sinupret extract coated tabletsDrug

    Also called Sinupret extract

    1 coated tablet 3 times a day for 16-weeks (1-1-1)

  • Placebo coated tabletsDrug

    Also called Placebo

    1 coated tablet 3 times a day for 16-weeks (1-1-1)

Study groups in NCT02746042
Study groupRoleWhat they receive
Sinupret extract coated tabletsExperimentalSinupret extract coated tablets: one tablet three times a day orally during the 16-week treatment phase. There will be no dose change during the trial.
Receives: Drug: Sinupret extract coated tablets
Placebo coated tabletsPlacebo comparatorPlacebo coated tablets: One tablet three times a day orally during the 16-week treatment Phase.
Receives: Drug: Placebo coated tablets

What is being measured

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

  1. MSS-INV at V7

    Major Symptom Score (MSS) assessed by the investigator at Visit 7 with Baseline as Covariate; The MSS considers: rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure

    Measured: 16 weeks

Secondary outcomes (25)

  1. MSS-INV at V4-6

    Major Symptom Score (MSS) assessed by the investigator at Visits 4, 5, and 6 with Baseline as Covariate

    Measured: 12 weeks

  2. MSS-PAT at V4-7

    Major Symptom Score (MSS) assessed by the Patient at Visits 4, 5, 6, and 7 with Baseline as Covariate

    Measured: 16 weeks

  3. Minimal MSS-INV at V4-7

    Minimal Major Symptom Score (MSS) assessed by the Investigator of all visits from Visits 4, 5, 6, and 7

    Measured: 16 weeks

  4. Minimal MSS-PAT at V4-7

    Minimal Major Symptom Score (MSS) assessed by the Patient of all visits from Visits 4, 5, 6, and 7

    Measured: 16 weeks

  5. Investigator's Ratings of CRS symptom

    Investigator's ratings of each individual CRS symptom (i.e. rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7

    Measured: 16 weeks

  6. Patient's Ratings of CRS symptom

    Patient's ratings of each individual CRS symptom (i.e. rhinorrhea [anterior], rhinorrhea [posterior], nasal congestion, headache, and facial pain/pressure) at V4, V5, V6, and V7

    Measured: 16 weeks

  7. SNOT-22

    22-Item Sino-Nasal Outcome Test (SNOT-22)Total Score as well as SNOT-22 primary nasal score (SNOT-22 PNS) and SNOT-22 general quality of life score (SNOT-22 ALQ) at V4, V5, V6, and V7

    Measured: 16 weeks

  8. VAS

    Total symptom severity assessed by the patient on a visual analogue scale (VAS) at V4, V5, V6, and V7

    Measured: 16 weeks

  9. Responder Rate

    Proportion of patients whose MSS-INV and MSS-PAT improved by ≥30%, ≥40%, ≥50%, ≥60% and ≥70% at V4, V5, V6, and V7. Responders are defined as patients who show at least an MSS improvement of ≥30%

    Measured: 16 weeks

  10. Concomitant drug and non-drug therapy

    Patients with permitted concomitant drug and non-drug therapy (i.e. isotonic saline solution as nasal spray, nasal irrigation [nasal lavage], or ultrasonic nebulizer) for CRS

    Measured: 22 weeks

  11. Premature Terminations

    Number of patients with premature termination due to exacerbation of CRS symptoms

    Measured: 20 weeks

  12. Investigator's and patient's overall assessment of efficacy (questionnaire)

    At each on-site visit during the treatment phase (V4 to V7), both the investigator and the patient have to provide an overall assessment of treatment efficacy using 5 categories ("very good", "good", "moderate", "poor", and "very poor"; ranges from 0 to 4).

    Measured: 16 weeks

  13. WPAI:GH questionnaire

    Pharmacoeconomic evaluation (utilization of health care resources) based on "Work Productivity and Activity Impairment, Global Health" (WPAI:GH) questionnaire completed by the patient at V4, V5, V6, and V7

    Measured: 22 weeks

  14. Inflammatory Parameter IL-1beta (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interleukin-1β (IL-1beta) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  15. Inflammatory Parameter IL-2 (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interleukin-2 (IL-2) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  16. Inflammatory Parameter IL-4 (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interleukin-4 (IL-4) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  17. Inflammatory Parameter IL-6 (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interleukin-6 (IL-6) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  18. Inflammatory Parameter IL-8 (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interleukin-8 (IL-8) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  19. Inflammatory Parameter IFN-gamma (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of interferon gamma (IFN-gamma) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  20. Inflammatory Parameter TNF-alpha (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of tumor necrosis factor alpha (TNF-alpha) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  21. Inflammatory Parameter MPO (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of myeloperoxidase (MPO) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  22. Inflammatory Parameter ECP (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of eosinophil cationic protein (ECP) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  23. Inflammatory Parameter alpha-2-macroglobulin (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of α2-macroglobulin (alpha-2-macroglobulin) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  24. Inflammatory Parameter HMGB-1 (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of high-mobility group box protein 1 (HMGB-1) in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

  25. Inflammatory Parameter albumin (nasal secretions: substudy)

    Absolute concentrations and total amount per sample of albumin in nasal secretions collected at V2, V5, and V7 for a subset of approximately 60 patients in selected investigational sites in Germany

    Measured: 16 weeks

Timeline

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

  1. First posted21 Apr 2016 (estimated)
  2. Study start28 Apr 2016
  3. Primary completion26 Jul 2017
  4. Study completion23 Aug 2017

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02746042
Sponsor's protocol ID
CRS-03
Other IDs
2015-001952-31, 2015
Status last verified
Dec 2017
First submitted
18 Apr 2016
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No: It is currently not planned to annex individual participant data (IPD) to publications of the study results.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sinupret extract coated tablets in people with Chronic Rhinosinusitis, run by Bionorica SE at 45 sites in 2 countries.

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 26 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Poland, Germany. 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?

MSS-INV at V7 (time frame: 16 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 NCT02746042.

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 28 Feb 2018.

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