Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy, a randomized, placebo controlled cross over study
- Conditions
- J30.1Allergic rhinitis due to pollen
- Registration Number
- DRKS00004312
- Lead Sponsor
- iversitätsklinikum Freiburg, Leitender ärztlicher Direktor
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 41
men and women aged between 18 - 50 years
-symptoms of grass polen allergy for at least 2 years (sneezing, itching of nose, running nose, tears)
-proof of allergy through prick test
-signed consent
•Chronic serious illness (i.e. diabetes mellitus type I, chronic polyarthritis, tumors, heart insufficiency, HIV-Infection)
•Asthma bronchiale with continuous therapy with inhalative or systemic steroides
•Hypersensitivity against compounds of Gencydo (quince, lemon)
•Treatment with Gencydo Nasal Spray within the last month before inclusion into the study
•Therapy with antihistamines, Cromoglycine acid, steroides or other antiallergic medication with 2 weeks before inclusion into the study
•anamnestic alcohol abuse >30g/d or iv. drug abuse
•pregnancy or breat feeding
•simultaneous participation in another clinical study within 3 months before inclusion into the study
• acute infection of airways or allergic reaction with distant symptoms
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Rhinomanometrically measured inspiratory nasal flow at 150 Pascal after provocation with grass pollen in an intraindividual comparison between Gencydo and placebo treatment
- Secondary Outcome Measures
Name Time Method Concentration of histamine in nasal lavage fluid after provocation with grass pollen in an intraindividual comparison between Gencydo and placebo