Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bitop AG
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in combined nasal symptom Score
Study Overview
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 Cromoglycid acid containing nasal spray. The patient applies Ectoin Allergy Nasal Spray or Cromoglycid acid containing 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 by the patient in a dairy at defined time intervalls.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female or male individuals ≥ 18 years
- •Patients with proven Allergic Rhinitis which are treated with Ectoin Nasal Spray or -Cromoglycic acid nasal Spray during the observational period
Exclusion Criteria
- •Contra indications according to the label
Arms & Interventions
Ectoin group
Ectoin Allergy Nasal Spray
Intervention: Medica device, drug-like (Other)
Cromolyn group
Cromolyn sodium
Outcomes
Primary Outcomes
Change in combined nasal symptom Score
Time Frame: Time Frame: day 1, day 7, day 14
The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.
Secondary Outcomes
- Patient's and physician's judgment of efficacy(Day 7 and 14)
- Eye itching score,(Day 1, 7, 14)
- Epiphora score(Day1, Day 7 and Day 14)
- Conjunctivitis score,(Day 1, Day 7 Day 10)
- Palatal itching score(Day 1, Day 7, Day 14)
- Nasal muscle hyperplasia score(Day 1, Day 7 and Day 14)