A Randomized, Double Blind, Placebo Controlled Multicenter Study to Assess the Efficacy and Safety of nasal spray ANTIRIN® and NASIC® in the Treatment of Allergic Rhinitis.
- Conditions
- RhinitisMedDRA version: 8.1Level: LLTClassification code 10039083
- Registration Number
- EUCTR2006-000435-99-CZ
- Lead Sponsor
- Zentiva a.s.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 207
•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
•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
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