A Randomised, Double Blind, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of nasal spray ANTIRIN® and NASIC® in the Treatment of Acute Viral Rhinitis

• Conditions: Rhinitis; MedDRA version: 8.1Level: LLTClassification code 10039083

• Registration Number: EUCTR2005-005876-33-CZ
• Lead Sponsor: Zentiva a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

•established diagnosis of acute viral rhinitis. All following criteria must be met:
odevelopment of nasal symptoms within 24 hours
opresence of nasal symptoms- congestion, rhinorrhea, nasal mucosa irritation ( itching or sneezing).
ooverall 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

•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:
osystemic corticosteroid drugs within 1 month prior inclusion
olocally administered corticosteroid drugs within 7 days prior inclusion
oantihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin,)
ouse of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 3 days prior inclusion
oMAO 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified