Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray
Completed
- Conditions
- Allergic Rhinitis
- Interventions
- Other: Medical Device, drug-likeDrug: Beclomethasone
- Registration Number
- NCT02133053
- Lead Sponsor
- Bitop AG
- Brief Summary
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Diagnosed allergic rhinitis during the observational period
Exclusion Criteria
- Contra indications according to the label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ectoin Group Medical Device, drug-like Ectoin Allergy Nasal Spray (Medical Device, drug-like) Beclomethasone Group Beclomethasone Beclomethasone nasal spray
- Primary Outcome Measures
Name Time Method Change in Total Nasal Symptom Score Time Frame: day 1, day 7, day 14
- Secondary Outcome Measures
Name Time Method Change in quality of life assessed by Rhinitis Quality of Life Questionnaire Day1 and Day 14 Change in palatal itching score Day 1, 7 and 14 Efficacy and tolerability assessment by the patients and by the investigator day 7 and 14