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Sinupret Extract Coated Tablets in Chronic Rhinosinusitis

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Bionorica SE
Sponsor:
Information provided by (Responsible Party):
Bionorica SE
ClinicalTrials.gov Identifier:
NCT02746042
First received: April 18, 2016
Last updated: December 2, 2016
Last verified: December 2016
  Purpose
To assess the efficacy of the herbal medicinal product Sinupret extract versus placebo in the treatment of chronic rhinosinusitis (CRS) in adults.

Condition Intervention Phase
Chronic Rhinosinusitis Drug: Sinupret extract coated tablets Drug: Placebo coated tablets Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Bionorica SE:

Primary Outcome Measures:
  • Major Symptom Score (MSS) assessed by the investigator at Visit 7 with Baseline as Covariate [ Time Frame: 16 weeks ]

Estimated Enrollment: 514
Study Start Date: April 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sinupret extract coated tablets

Sinupret 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.

Drug: Sinupret extract coated tablets
1 coated tablet 3 times a day for 16-weeks (1-1-1)
Placebo Comparator: Placebo coated tablets
Placebo coated tablets: One tablet three times a day orally during the 16-week treatment Phase.
Drug: Placebo coated tablets
1 coated tablet 3 times a day for 16-weeks (1-1-1)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent (IC) including data protection declaration
  2. 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).

  3. 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)
  4. 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)

Exclusion Criteria:

  1. Sinus surgery within the last 2 years (solitary sinus puncture is allowed)
  2. Inferior turbinate reduction (by surgery or other methods) within the last 3 months
  3. Presence or history of uni- or bilateral nasal polyps
  4. Moderate to severe co-morbid asthma, including allergic asthma
  5. Cystic fibrosis
  6. Perennial (e.g. patients with clinical symptoms of allergic rhinitis against house dust/mite antigen) or seasonal allergic rhinitis
  7. Rhinitis medicamentosa (drug induced rhinitis)
  8. Aspirin-exacerbated respiratory disease (aspirin sensitivity)
  9. Dentogenic sinusitis or otherwise unilateral sinusitis
  10. Presence of anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow
  11. Known hypersensitivity to trial medication or excipients
  12. Rare hereditary problems of fructose intolerance, galactose intolerance, lactase deficiency, glucose-galactose malabsorption, or sucrase- isomaltase insufficiency
  13. Signs or symptoms of acute bacterial sinusitis (e.g. fever >38.5°C, orbital complications, severe unilateral frontal headache, or toothache)
  14. Treatment with antihistamines within 4 weeks prior to V1
  15. Treatment with 2-3.5% hypertonic saline solution within 2 weeks prior to V1
  16. Treatment with systemic or nasal antibiotics or corticosteroids within 4 weeks prior to V1
  17. 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
  18. Peptic ulcer
  19. Gastritis
  20. 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)
  21. 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
  22. 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)
  23. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the clinical trial
  24. Patients in custody by juridical or official order
  25. Patients who have difficulties in understanding the local language in which the patient information (PI) is given
  26. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02746042

Contacts
Contact: Christoph Strehl, Dr. + 49 9181 231 - 7207 crs-03@bionorica.de
Contact: Dimitri Abramov-Sommariva

  Show 54 Study Locations
Sponsors and Collaborators
Bionorica SE
Investigators
Principal Investigator: Jürgen Palm, Dr. Praxis Dr. Jürgen Palm, 90552 Röthenbach/Pegnitz, Germany
  More Information

Responsible Party: Bionorica SE
ClinicalTrials.gov Identifier: NCT02746042     History of Changes
Other Study ID Numbers: CRS-03
2015-001952-31 ( EudraCT Number )
Study First Received: April 18, 2016
Last Updated: December 2, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: It is currently not planned to annex individual participant data (IPD) to publications of the study results.

Keywords provided by Bionorica SE:
chronic rhinosinusitis
Sinupret extract
herbal medicinal product

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017