Rhinitis MedDRA version: 8.1 Level: LLT Classification code 10039083
Conditions
Sponsors
Zentiva a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • established diagnosis of acute viral rhinitis. All following criteria must be met: o development of nasal symptoms within 24 hours o presence of nasal symptoms- congestion, rhinorrhea, nasal mucosa irritation ( itching or sneezing). o overall viral symptoms (at least one of them should be present) – weakness, headache, myalgia, arthralgia. (Febrile patients are not excluded from the trial.) • patients between 18 – 60 years, both sexes. • written informed consent obtained . • TNSS score on inclusion ( day 0) = 5. • the patient can be contacted by phone 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with history of allergic rhinitis, rhinitis sicca or rhinitis medicamentosa • pregnant or lactating women • patients with the history of bronchial asthma • patients with history of nose surgery, after the injury of the facial skelet, after actinotherapy of the facial region • patients with the history of endocrine disease • patients with the history of narrow angle glaucoma • patients taking the following drugs: o systemic corticosteroid drugs within 1 month prior inclusion o locally administered corticosteroid drugs within 7 days prior inclusion o antihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin,) o use of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 3 days prior inclusion o MAO inhibitors and other drugs with hypertensive potential within 7 days prior inclusion • patients with the history of nasal polyps • any other disease or condition which may interfere with study assessments as judged by the investigator • alcohol or drug abuse • patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months • patients with history of hypersensitivity to the study drug or its excipients • clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension • patients with pheochromocytoma • patients presenting any malignant disease • patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the study drug ANTIRIN® is at least as effective (non-inferiority testing) assessed by TNSS changes after 4 days of therapy as the comparative product NASIC® in the treatment of acute viral rhinitis, to compare ANTIRIN® with placebo to proof of its efficacy and to compare NASIC® with placebo to proof assay sensitivity.;Secondary Objective: To determine efficacy assessed by VAS changes mearusing intensity of all individual symptoms (runny nose, sneezing, nasal itching and congestion) To determine the safety and tolerability of ANTIRIN®. ;Primary end point(s): Primary efficacy parameter will be the absolute change from baseline to Day 4 in patient self-rated TNSS. The TNSS include a composite score of runny nose, sneezing, nasal itching and congestion. All symptoms are rated using four-point scale with following interpretation: 0 = absent symptoms (no sign/symptom evident) 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated) 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable) 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The baseline value for TNSS is defined as the last measurement taken prior to application of test/reference drug. Day 4 assessment of TNSS was defined as endpoint (LOCF imputation technique will be used on ITT set). | — |
Countries
Czech Republic
Outcome results
None listed