Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Information source: Bitop AG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinoconjunctivitis
Phase: N/A
Status: Completed
Sponsored by: Bitop AG Official(s) and/or principal investigator(s): Uwe Sonnemann, MD, Principal Investigator, Affiliation: HNO Praxis Elmshorn
Summary
This is a comparative, open label, parallel group, non interventional study to further
demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops.
In addition the effectiveness and safety shall be compared to Azelastine containing nasal
Sprays and Eye drops. The patient applied EctoinŽ Rhinitis Nasal Spray / Eye drops or takes
Azelastine nasals spray and eye drops according to the instructions for use. The observation
takes place over a period of 7 days. Response to treatment is recorded at day 7 by the
physician and in daily by the patient in a dairy.
Clinical Details
Official title: Non-interventional Study: Application of EctoinŽ Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Change in primary allergic symptoms symptoms
Secondary outcome: Palatal itching scoreEfficacy and tolerability assessment by the patients
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- male or female patients
- aged 18-70 years
- Patients with proven allergy and acute symptoms in nose and eye which are treated
with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal
Spray and Azelastine Eye Drops during the observational period
Exclusion Criteria:
- pregnancy and nursing women,
- drug addicts and persons unable to give consent to study participation,
- patients with intolerance against ingredients of any of the study treatments,
- previous eye or nose surgery,
- concomitant treatment with anti-allergic drugs, and
- diseases which might influence the output of the study according to the physicians'
judgment.
- contra indications according to the label
Locations and Contacts
HNO Praxis Elmshorn, Elmshorn, Germany
Additional Information
Starting date: June 2010
Last updated: May 5, 2014
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