Rhinitis MedDRA version: 8.1 Level: LLT Classification code 10039083
Conditions
Sponsors
Zentiva a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •allergic rhinitis in last 2 years at least •positive skin test or specific IgE to allergens in the medical history •patients between 18 – 60 years, males and females •informed consent form signed •he patient can be reached 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Asthma, with the exception of mild intermittent asthma •Systemic corticoids taken in last 1 month •Immunotherapy started in less than 1 month prior to the enrollment •antihypertensive drugs that may influence nasal congestion within 7 days prior to inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin,) •MAO inhibitors and other drugs with hypertensive potential within 7 days prior to inclusion •Chronic use of concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication •Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator •Patients with history of hypersensitivity to the study medication or its excipients •Rhinitis medicamentosa •pregnant or lactating women •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 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 •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 day-therapy as the comparative product NASIC® in the treatment of allergic rhinitis and to compare ANTIRIN® with placebo to prove its efficacy and to compare NASIC® to placebo to prove assay sensitivity.;Secondary Objective: 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 is a score evaluating four factors: 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