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

• Sponsor: Bitop AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02133053
• Collaborator: (none)
• Enrollment: 50
• Duration (Months): 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Other: Medical Device, drug-like; Drug: Beclomethasone

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Ectoin Group Ectoin Allergy Nasal Spray (Medical Device, drug-like)	Other: Medical Device, drug-like; Ectoin Allergy Nasal Spray
Beclomethasone Group Beclomethasone nasal spray	Drug: Beclomethasone; Beclomethasone nasal spray

Outcome Measures

Primary Outcome Measures

1. Change in Total Nasal Symptom Score [Time Frame: day 1, day 7, day 14]

Secondary Outcome Measures

1. Change in palatal itching score [Day 1, 7 and 14]

2. Efficacy and tolerability assessment by the patients and by the investigator [day 7 and 14]

3. Change in quality of life assessed by Rhinitis Quality of Life Questionnaire [Day1 and Day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

• Contra indications according to the label

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bitop AG

Investigators

• Principal Investigator: Uwe Sonnemann, MD, HNO Praxis Elmshorn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bitop AG
• ClinicalTrials.gov Identifier: NCT02133053
• Other Study ID Numbers: PPL-042
• First Posted: May 7, 2014
• Last Update Posted: May 7, 2014
• Last Verified: May 1, 2014

• Keywords provided by Bitop AG: Allergic Rhinitis; Ectoine; bitop; Ectoin
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Beclomethasone

Study Results

No Results Posted as of May 7, 2014