Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray

Allergic Rhinitis Clinical Trial

Official title:

Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133053
• Other study ID #: PPL-042
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: May 6, 2014
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: May 2014
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

• Contra indications according to the label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Other:
• Medical Device, drug-like
Ectoin Allergy Nasal Spray

Drug:
• Beclomethasone
Beclomethasone nasal spray

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Nasal Symptom Score		Time Frame: day 1, day 7, day 14	No
Secondary	Change in palatal itching score		Day 1, 7 and 14	No
Secondary	Efficacy and tolerability assessment by the patients and by the investigator		day 7 and 14	Yes
Secondary	Change in quality of life assessed by Rhinitis Quality of Life Questionnaire		Day1 and Day 14	No