EUCTR2006-000435-99-CZActive, not recruitingNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zentiva a.s.
- Enrollment
- 207
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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