A Randomized, Double Blind, Placebo Controlled Multicenter Study to Assess the Tolerability and Safety of ANTIRIN® nasal spray and drops in two Age Groups of Children with Acute Rhinitis

Phase 1

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

• Registration Number: EUCTR2006-005461-19-CZ
• Lead Sponsor: Zentiva a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

To participate in this trial, patients will have to meet all of the following criteria:

•established diagnosis of acute rhinitis. All following criteria must be met:
othe occurrence of two nasal symptoms at least: congestion, rhinorrhea, mucosa burning or itching, sneezing
oduration of nasal symptoms = 30 days

•no topical decongestives during last 7 days
•patients between 2 – 7 years, both genders ……Group I
•patients between 8 – 18 years, both genders ……Group II
•written informed consent obtained of patient s guardian and patient (if possible)
•good collaboration with parents

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Patients meeting any of the following criteria will be excluded from participation in this study:

•Rhinitis which originated before more than 30 days
• Rhinitis medicamentosa
•Rhinitis sicca
•Otitis media
•patients with unstable bronchial asthma
•patients with unstable endocrine disease
•patients with the history of narrow angle glaucoma
•patients with history of hypersensitivity to the study drug or its excipients
•patients taking the following drugs:
othe need of administration of local (nasal) corticosteroid drugs
ouse of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 7 days prior inclusion
oSystemic corticosteroids: changes in dose within 7 days prior inclusion
oAntihistamin drugs: changes in dose 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)
oMAO inhibitors and other drugs with hypertensive potential within 14 days prior inclusion.
•patients with the history of nasal polyps
•patients with major nasal septum deviation
•pregnancy
•any other disease or condition which may interfere with study assessments as judged by the investigator
•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

Study & Design

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