acute uncomplicated rhinosinusitis MedDRA version: 20.0 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862
Conditions
Sponsors
Repha GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. signed informed consent 2. male and female outpatients aged =18 und =75 Jahre 3. diagnosis of acute (or recurrend acute) rhinosinusitis: - characterized by the main symptoms with an MRSSinv score between 8 and 12 Points - evidence of nasal congestion and facial pain / facial pressure is mandatory - single score for facial pain / facial pressure = 1 (slight) und = 2 (moderate) - symptoms occured = 3 days before study enrolment 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: Medical history a) Diseases 1. Chronic rhinosinusitis (i.e. all forms and causes of persistent chronic rhinosinusitis;) 2. known nasal polyps (Polyposis nasi) 3. Cystic fibrosis 4. Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation / air flow 5. Acute symptoms of a known allergic Rhinitis (Hayfever) 6. Clinically relevant findings in laboratory values (i. e. more than three times deviating from the upper or lower norm of the laboratory or significant in as assessed by the investigator respectively) 7. Patients with asthma 8. Known hypersensitivity to study medication / placebo or respective excipients 9. Any contraindications to the study medication 10. known immune deficient patients 11. Signs or symptoms of fulminant bacterial sinusitis (e.g. fever > 38.5 °C, orbital complications, severe unilateral frontal headache or toothache) 12. Severe diseases of liver or kidney 13. Severe somatopathic, neurological and / or psychiatric diseases 14. Patients with malignant growth processes or cancer treatment within the last five years (head / neck Treatments) and / or within the last 2 years (other body regions) prior to study inclusion. 15. Any condition which might interfere with study objectives or that would limit the patients ability to complete the study as judged by the investigator 16. History of alcohol or drug abuse Medical history b) Medication 1. Treatment with immunosuppressive medication 8 weeks prior to screening and during the study for any condition 2. Treatment with systemic or nasal antibiotics or nasal or systemic corticosteroids within the last 30 daysprior to study inclusion 3. Systemic antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to visit 1. 4. Treatment with alternative medicinal preparations for treatment of common cold like symptoms or with immunomodulating properties, within the last 7 days prior to study inclusion 5. Patients requiring antibiotic treatment for any condition at study entry Medical history c) General 1. Parallel participation in any other clinical study, participation in another study within less than 6 weeks prior to study entry, or previous participation in this same study 2. Pregnant, lactating women or women capable of bearing children rejecting the use of reliable contraceptives (Pearl-lndex < 1) 3. Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study 4. Patients in custody by juridical or official order 5. Uncooperative patients 6. Patients who have difficulties in understanding the language (German) in which the patient information is given 7. Patients who are in a dependent relationship with the Sponsor, the investigator, other study team members, or the study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Difference in the mean symptom scores MRSSinv/MRSSpat between both treatment Groups in the course of the treatment Phase (V1 to V5);Secondary Objective: - Change of single symptoms MRSSinv between V1, V2, V3, V4 and V5 and within the course of the study - Change of single symptoms MRSSpat between V1, V2, V3, V4 and V5 and within the course of the study - time until ARS is cured (V1 - V5) - rate of cured patients (V1-V5) - comparison of recurrences between V1 and V5 - Changes in SNOT-20 GAV between V1, V3 and V5 - Changes in SNOT-20 GAV GS between V1, V3 and V5 - Changes in SNOT-20 GAV PNS between V1, V3 and V5 - Changes in SNOT-20 GAV SRS between V1, V3 and V5 - Changes in SNOT-20 GAV ALQ between V1, V3 and V5 - Evaluation of efficacy by the investigator (V2, V3, V4, V5) - consumption of rescue medication between Groups - use of rescue measures between Groups - compliance - UEs in the course of the trial - vital signs to V1, V3, V5 - clinical chemistry and hematology to V1, V3, V5 - Evaluation of tolerability by investigator and patient at V5 ;Primary end point(s): Difference in the mean symptom scores MRSSinv/MRSSpat between both treatment Groups in the course of the treatment Phase (V1 to V5);Timepoint(s) of evaluation of this end point: After the Treatment Phase (max. 16 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change of single symptoms MRSSinv between V1, V2, V3, V4 and V5 and within the course of the study - Change of single symptoms MRSSpat between V1, V2, V3, V4 and V5 and within the course of the study - time until ARS is cured (V1 - V5) - rate of cured patients (V1-V5) - comparison of recurrences between V1 and V5 - Changes in SNOT-20 GAV between V1, V3 and V5 - Changes in SNOT-20 GAV GS between V1, V3 and V5 - Changes in SNOT-20 GAV PNS between V1, V3 and V5 - Changes in SNOT-20 GAV SRS between V1, V3 and V5 - Changes in SNOT-20 GAV ALQ between V1, V3 and V5 - Evaluation of efficacy by the investigator (V2, V3, V4, V5) - consumption of rescue medication between Groups - use of rescue measures between Groups - compliance - UEs in the course of the trial - vital signs to V1, V3, V5 - clinical chemistry and hematology to V1, V3, V5 - Evaluation of tolerability by investigator and patient at V5 ;Timepoint(s) of evaluation of this end point: After Treatment Phase (max. 16 days) | — |
Countries
Germany
Contacts
Public ContactClinical Research
Mediconomics GmbH
Outcome results
None listed