A multi-centre, randomised, placebo-controlled, double-blind parallel-group trial to assess the efficacy and safety of SIA capsules in subjects with acute rhinosinusitis.
- Conditions
- acute rhinosinusitisMedDRA version: 20.0Level: LLTClassification code 10040754Term: Sinusitis acute NOSSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-001717-17-DE
- Lead Sponsor
- Pohl-Boskamp GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 456
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of orally administered essentials oils (SIA capsules) compared with placebo for 2 weeks in adults with acute rhinosinusitis.<br>;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)<br>2.Difference in mean MSS(INV) scores at Visit 3 (SIA vs. placebo)<br>;Timepoint(s) of evaluation of this end point: Visit 3 and Visit 4
- Secondary Outcome Measures
Name Time Method