A multi-centre, double-blind, placebo-controlled, randomised, parallel group study to assess the efficacy and safety of a herbal medicinal product (dry extract BNO-1016) in patients with acute rhinosinusitis.Multi-centre, double-blind, placebo-controlled, randomised, parallel group study

• Conditions: MedDRA version: 12.0Level: LLTClassification code 10052106Term: Rhinosinusitis; Acute rhinosinusitis

• Registration Number: EUCTR2009-016682-28-DE
• Lead Sponsor: Bionorica AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-04
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Signed informed consent and data protection declaration
2.Male and female outpatients aged =18 and = 75 years
3.Diagnosis of acute rhinosinusitis
-characterised by a major symptom score* (MSS) = 8 and =12 points
(range: mini-mum 0, maximum 15 points)
-individual score for facial pain / pressure = 1 (mild) and = 2 (moderate)
-confirmed by ultrasonography of paranasal sinuses
-with presence of symptoms = 3 days prior to inclusion

*Out of the 5 main rhinosinusitis symptoms at least 3 must be present. Among these the presence of nasal con-gestion and facial pain / pressure is mandatory.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Chronic rhinosinusitis
2.Polyposis nasi
3.Cystic fibrosis
4.Anatomical deviations of the nasal septum that significantly impair nasal
and paranasal ventilation / airflow
5.Acute symptoms of a known allergic rhinitis
6.Patients with asthma who have a history of exacerbations within 30 days
prior to study inclusion
7.Known hypersensitivity to study medication or excipients
8.Underlying diseases leading to significant immune deficiency
9.Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C,
orbital complications, severe unilateral frontal headache or toothache)
10.Odontogenic sinusitis
11.Treatment with systemic or nasal antibiotics or nasal or systemic
corticosteroids (excluding inhaled corticosteroids for mild to moderate
persistent asthma) within the last 4 weeks prior to study inclusion
12.Treatment with decongestant preparations, analgesics (including systemic
NSAIDs, except Paracetamol), mucolytics / secretolytics, antihistamines, or
alternative medicine preparations for treatment of common cold like
symptoms or with immunomodulating properties within the last 7 days
prior to study inclusion
13.Patients requiring antibiotic treatment for any condition at study entry
14.Pregnancy or lactation
15.Severe diseases of liver or kidney
16.Severe somatopathic, neurological and / or psychiatric diseases
17.Malignant growth (actual, condition after carcinoma not longer than
5 years without relapse)
18.History of alcohol or drug abuse
19.Parallel participation in another study, participation in a study within less
than 6 weeks prior to study entry, or previous participation in this same
study
20.Known to be, or suspected of being unable to comply with the study
protocol (e.g. no permanent address, history of drug abuse, known to be
non-compliant or presenting an unstable psychiatric history)
21.Legal incapacity and / or other circumstances rendering the patient unable
to understand the nature, scope and possible impact of the study
22.Patients in custody by juridical or official order
23.Evidence of an uncooperative attitude
24.Patients who have difficulties in understanding the language (German) in
which the patient information is given
25.Patients who are members of the staff of the study centre, staff of the
sponsor or 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