Allergic Rhinitis
Conditions
Keywords
Allergic Rhinitis, Ectoine, bitop, Ectoin
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.
Interventions
Ectoin Allergy Nasal Spray
DRUGBeclomethasone
Beclomethasone nasal spray
Sponsors
Bitop AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed allergic rhinitis during the observational period
Exclusion criteria
* Contra indications according to the label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total Nasal Symptom Score | Time Frame: day 1, day 7, day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in quality of life assessed by Rhinitis Quality of Life Questionnaire | Day1 and Day 14 |
Outcome results
None listed