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

NCT02131038 | Completed

• 1 other identifier: Rep-25
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Ectoine; bitop; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Ectoin group

Ectoin Allergy Nasal Spray

Other: Medica device, drug-like

Cromolyn group

Cromolyn sodium

Interventions

Medica device, drug-like OTHER

Ectoin (R) Allergy Nasal Spray

Ectoin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• 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

You may not qualify if:

• Contra indications according to the label

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

HNO Praxis Elmshorn

Elmshorn, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Uwe Sonnemann, MD

  HNO Praxis Elmshorn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

DE (1)