Sinupret Extract Coated Tablets in Chronic Rhinosinusitis

NCT02746042 | Completed Phase 3

• 2 other identifiers: CRS-032015-001952-31
• Study Type: interventional
• Target: 572
• Locations: 2 countries
• Sites: 45

Brief Summary

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

Conditions

Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis; Sinupret extract; herbal medicinal product

Outcome Measures

Primary Outcomes (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

  16 weeks

Secondary Outcomes (25)

• MSS-INV at V4-6

  12 weeks

• MSS-PAT at V4-7

  16 weeks

• Minimal MSS-INV at V4-7

  16 weeks

• Minimal MSS-PAT at V4-7

  16 weeks

• Investigator's Ratings of CRS symptom

  16 weeks

Other Outcomes (1)

• Safety Endpoints

  22 weeks

Study Arms (2)

Sinupret extract coated tablets

EXPERIMENTAL

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

Placebo coated tablets

PLACEBO COMPARATOR

Placebo coated tablets: One tablet three times a day orally during the 16-week treatment Phase.

Drug: Placebo coated tablets

Interventions

Sinupret extract coated tablets DRUG

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

Also known as: Sinupret extract

Sinupret extract coated tablets

Placebo coated tablets DRUG

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

Also known as: Placebo

Placebo coated tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent (IC) including data protection declaration
• Male and female outpatients aged ≥18 and ≤75 years
• 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)
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bionorica SE: lead

Study Sites (45)

Bionorica Investigative Site

Berlin, 13353, Germany

Location

Bionorica Investigative Site

Braunschweig, Germany

Location

Bionorica Investigative Site

Chemnitz, Germany

Location

Bionorica Investigative Site

Dresden, 01067, Germany

Location

Bionorica Investigative Site

Dresden, 01139, Germany

Location

Bionorica Investigative Site

Dresden, 01159, Germany

Location

Bionorica Investigative Site

Dresden, 01307, Germany

Location

Bionorica Investigative Site

Duisburg, Germany

Location

Bionorica Investigative Site

Essen, Germany

Location

Bionorica Investigative Site

Frankfurt am Main, Germany

Location

Bionorica Investigative Site

Göttingen, Germany

Location

Bionorica Investigative Site

Heidelberg, 69120, Germany

Location

Bionorica Investigative Site

Heidelberg, 69126, Germany

Location

Bionorica Investigative Site

Markkleeberg, Germany

Location

Bionorica Investigative Site

Mittweida, Germany

Location

Bionorica Investigative Site

Munich, 80331, Germany

Location

Bionorica Investigative Site

Neuenhagen, Germany

Location

Bionorica Investigative Site

Nuremberg, Germany

Location

Bionorica Investigative Site

Röthenbach/Pegnitz, Germany

Location

Bionorica Investigative Site

Schlüchtern, Germany

Location

Bionorica Investigative Site

Schorndorf, Germany

Location

Bionorica Investigative Site

Wuppertal, Germany

Location

Bionorica Investigative Site

Bialystok, 15-270, Poland

Location

Bionorica Investigative Site

Bialystok, 15-879, Poland

Location

Bionorica Investigative Site

Bydgoszcz, Poland

Location

Bionorica Investigative Site

Gdansk, Poland

Location

Bionorica Investigative Site

Gdynia, Poland

Location

Bionorica Investigative Site

Katowice, 40-036, Poland

Location

Bionorica Investigative Site

Katowice, 40-611, Poland

Location

Bionorica Investigative Site

Katowice, 40-954, Poland

Location

Bionorica Investigative Site

Kielce, Poland

Location

Bionorica Investigative Site

Krakow, 30-349, Poland

Location

Bionorica Investigative Site

Krakow, 30-548, Poland

Location

Bionorica Investigative Site

Krakow, 31-624, Poland

Location

Bionorica Investigative Site

Limanowa, Poland

Location

Bionorica Investigative Site

Lodz, Poland

Location

Bionorica Investigative Site

Lublin, 20-552, Poland

Location

Bionorica Investigative Site

Piaseczno, Poland

Location

Bionorica Investigative Site

Szczecin, Poland

Location

Bionorica Investigative Site

Tychy, Poland

Location

Bionorica Investigative Site

Warsaw, 01-868, Poland

Location

Bionorica Investigative Site

Wieliczka, Poland

Location

Bionorica Investigative Site

Wroclaw, Poland

Location

Bionorica Investigative Site 222

Zgierz, Poland

Location

Bionorica Investigative Site 224

Zgierz, Poland

Location

MeSH Terms

Interventions

Sinupret

Study Officials

• Jürgen Palm, Dr.

  Praxis Dr. Jürgen Palm, 90552 Röthenbach/Pegnitz, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: April 28, 2016
• Primary Completion: July 26, 2017
• Study Completion: August 23, 2017
• Last Updated: February 28, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (22); PL (23)