Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray in Patients With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131038
• Other study ID #: Rep-25
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: May 5, 2014
• Start date: May 2009
• Est. completion date: September 2009

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Other:
• Medica device, drug-like
Ectoin (R) Allergy Nasal Spray

Locations

Country	Name	City	State
Germany	HNO Praxis Elmshorn	Elmshorn

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in combined nasal symptom Score	The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.	Time Frame: day 1, day 7, day 14	No
Secondary	Patient's and physician's judgment of efficacy	Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8.	Day 7 and 14	No
Secondary	Eye itching score,		Day 1, 7, 14	No
Secondary	Epiphora score		Day1, Day 7 and Day 14	No
Secondary	Conjunctivitis score,		Day 1, Day 7 Day 10	No
Secondary	Palatal itching score		Day 1, Day 7, Day 14	No
Secondary	Nasal muscle hyperplasia score		Day 1, Day 7 and Day 14	No