acute rhinosinusitis MedDRA version: 20.0 Level: LLT Classification code 10040754 Term: Sinusitis acute NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: GeloMyrtol forte
Product Name: SIA 300 mg capsule
Product Code: R05CP
Pharmaceutical Form: Capsule
INN or Proposed INN: DISTILLATE OF A MIXTURE OF RECTIFIED EUCALYPTUS OIL, RECTIFIED SWEET
Sponsors
Pohl-Boskamp GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent for trial participation and handling of personal data in concurrence with the European General Data Protection Declaration (GDPR) has been obtained prior to performance of any trial specific procedures or assessments 2. Male or female outpatient adults aged =18 years 3. Clinically evident diagnosis of acute rhinosinusitis 4. Severity of the five main rhinosinusitis symptoms (MSS) characterised as follows based on the investigator’s ratings at Visit 1 (screening): - Sum score MSSINV =8 points and =12 points - Individual score for facial pain/ pressure =1 (mild) and =2 (moderate) 5. Presence of rhinosinusitis symptoms for 3 days or less (i.e. symptoms started =3 days before Visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 96
Exclusion criteria
Exclusion criteria: 1. Acute symptoms of a known allergic rhinitis 2. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever >38.5°C), orbital complications, severe unilateral frontal headache or toothache) 3. History of chronic rhinosinusitis with exacerbations within 6 months prior to Visit 1 4. History of polyposis nasi 5. History of odontogenic sinusitis 6. History of chronic nasal congestion (e.g. due to known anatomical deviations of the nasal septum etc.) 7. Paranasal sinus surgery up to two years prior to Visit 1 8. History of cystic fibrosis 9. History of asthma with exacerbations (asthma attacks) within the past 30 days prior to Visit 1 10. Known hypersensitivity to trial medication or excipients 11. Underlying diseases leading to significant immune deficiency 12. Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct at the time of inclusion or within the last 6 months before Visit 1. 13. History of severe somatopathic, neurological and/ or psychiatric diseases 14. Malignant growth (actual, condition after carcinoma less than 5 years without relapse) 15. Only for female subjects of childbearing potential: Woman who is pregnant or breast feeding, or without highly effective contraception (failure rate less than 1%) 16. Treatment with systemic antibiotics, or with nasal or systemic corticosteroids within the last 4 weeks prior to Visit 1 (excluding inhaled corticosteroids for mild to moderate persistent asthma) 17. Treatment with mucolytics/ secretolytics, antihistamines, or alternative medicine preparations or drugs with immunomodulating properties within the last 7 days prior to Visit 1 18. Use of paracetamol, decongestant preparations, systemic analgesics (including systemic non-steroidal anti-inflammatory drugs [NSAIDs]), the day of Visit 1 (before randomisation) 19. History or presence of drug or alcohol abuse 20. Parallel participation in another clinical trial with an investigational product, participation in a clinical trial within less than 6 weeks prior to Visit 1 21. Known to be, or suspected of being unable to comply with the trial protocol (e.g., no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history) 22. Legal incapacity and/ or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the trial 23. Subject in custody by juridical or official order 24. Subject who has difficulties in understanding the language (German) in which the subject information (informed consent form) is given 25. Subjects who are members of the staff of the trial centre, staff of the sponsor or the clinical research organisation (CRO), the investigator him-/ herself or close relatives of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of orally administered essentials oils (SIA capsules) compared with placebo for 2 weeks in adults with acute rhinosinusitis. ;Secondary Objective: To assess the safety of 2 weeks of oral treatment with essentials oils (SIA capsules) compared with placebo in adults with acute rhinosinusitis. ;Primary end point(s): 1. Difference in mean MSS(INV) scores at Visit 4 (SIA vs. placebo) 2. Difference in mean MSS(INV) scores at Visit 3 (SIA vs. placebo) ;Timepoint(s) of evaluation of this end point: Visit 3 and Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference in mean MSSPAT scores in the evening before Visit 3 (SIA vs. placebo) 2. Difference in mean MSSPAT scores in the evening before Visit 4 (SIA vs. placebo) 3. Difference in mean MSSINV scores at Visit 2 (SIA vs. placebo) 4. Difference in mean MSSPAT scores in the evening before Visit 2 (SIA vs. placebo) The secondary efficacy endpoint “Differences in responder rates at Visits 2, 3 and 4 (SIA vs. placebo)” will be analysed using the generalized linear mixed model with binary outcome using Baseline (Visit 1) as covariate, patient as random effect repeated in visit. The respective visit (Visit 2, Visit 3 or Visit 4) will be selected from the model by using respective contrasts. . A responder is defined by the investigator’s and subject’s assessments according to the definition in chapter 9.11. The order of testing will be as follows: 5. Difference in responder rates at Visit 4 (SIA vs. placebo) by investigator 6. Difference in responder rates at Visit 4 (SIA vs. placebo) by patient 7. Difference in responder rates at Visit 3 (SIA vs. placebo) by investigator 8. Difference in responder rates at Visit 3 (SIA vs. placebo) by Patient 9. Difference in responder rates at Visit 2 (SIA vs. placebo) by investigator 10. Difference in responder rates at Visit 2 (SIA vs. placebo) by patient ;Timepoint(s) of evaluation of this end point: Visit 2, Visit 3, Visit 4 and diary data over 15 days treatment period | — |
Countries
Germany
Contacts
Public ContactDirector Medicine & Clin. Research
Pohl-Boskamp GmbH & Co. KG
Outcome results
None listed