Acute Rhinosinusitis
Conditions
Interventions
Trade Name: Tavipec®
Product Name: tavipec
Pharmaceutical Form: Capsule
INN or Proposed INN: spicae
CAS Number: 8016-87-2
Other descriptive name: OLEUM SPICAE
Concentration unit: g gram(s)
Concentrat
Sponsors
Montavit Ges.m.b.H.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and female outpatients aged = 18 - 75 years 2. Acute rhinosinusitis complying with following symptoms: o Rhinorrhea o Postnasal drip o Nasal congestion/stuffiness o Sinus headache o Facial pain o Reduction/loss of smell (hyposmie) 3. Sublingual temperature 5 but =65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: - Signs or symptoms suggestive of acute bacterial rhinosinusitis (sublingual temperature >38.3°C, persistent severe unilateral facial or tooth pain, facial swelling, severe frontal or retroorbital pain radiating to the occiput) or of extrasinus manifestations, such as orbital cellulitis, dental or facial abscess, cavernous vein thrombosis - Chronic recurrent rhinosinusitis with more than 4 episodes of acute rhinosinusitis per year and no complete resolution in-between - Immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa - Known or suspected hypersensitivity to the active substance and/or to any of the excipients - Need for antibiotic treatment in patients at high risk of serious complications because of pre-existing comorbidity, including significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, human immunodeficiency virus infection, malignancy other than squamous or basal cell carcinoma of the skin - Antibiotic therapy (local or systemic) at any time during the preceding four weeks - Need for application of concomitant local medications including antibiotics, corticosteroids, antihistaminic agents - Immunosuppressive therapy and/or systemic corticosteroids - Systemic antihistaminic agents - Radiation therapy or chemotherapy within the previous 12 months - Pregnancy or lactating women - History of alcohol or drug abuse likely to lead to uncooperative behavior - History of psychiatric and/or neurological illness likely to lead to uncooperative behavior - Participation in another clinical trial within 1 month - Patients using medication for treatment of common cold like symptoms (excluding nasal douche)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose;Secondary Objective: - - Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose - % of patients with improvement of health-related QOL score as revealed by SNOT 22 by at least ten score points - Global impact of disease on QOL as assessed by patient - Adverse event rate ;Primary end point(s): Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose ;Timepoint(s) of evaluation of this end point: after 4 days of full medication dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - - Mean difference of an investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 4 days of full medication dose - Mean difference of the adapted investigator-evaluated Major Symptom Score (MSS) of 20% between the verum group and the placebo group after 7 days of full medication dose - % of patients with improvement of health-related QOL score as revealed by SNOT 22 by at least ten score points - Global impact of disease on QOL as assessed by patient - Adverse event rate ;Timepoint(s) of evaluation of this end point: at baseline; after 4 and 7 days of full medication dose | — |
Countries
Austria, Poland
Contacts
Public Contactclinical trial manager
Montavit
Outcome results
None listed