Efficacy and Safety of Tavipec versus Placebo in patients with acute Rhinosinusitis
- Conditions
- Acute RhinosinusitisTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-002977-23-AT
- Lead Sponsor
- Montavit Ges.m.b.H.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Adult male and female outpatients aged = 18 - 75 years
2.Acute rhinosinusitis complying with following symptoms:
oRhinorrhea
oPostnasal drip
oNasal congestion/stuffiness
oSinus headache
oFacial pain
oReduction/loss of smell (hyposmie)
3.Sublingual temperature < 38.3°C, no dental involvement, impairment of general conditions.
4.Major Symptom Score (MSS) (> 5 but < 12)
5.ARS symptoms at enrolment do not exceed 3 days
6.Informed consent and willingness to comply with the protocol
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280
-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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method