Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

NCT02131051 | Completed

• 1 other identifier: REP-85
• Study Type: observational
• Target: 48
• 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 and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® 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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

ectoine; allergic rhinitis; bitop

Outcome Measures

Primary Outcomes (1)

• Change in primary allergic symptoms symptoms

  Change in the primary allergic nasal and ophthalmic symptoms: Degree of nasal breathing impairment, Rhinorrhea, Frequency of sneezing, Nasal itching,Eye itching, Watery eyes, Conjunctivitis score (eye redness)

  Day1, Day 7

Secondary Outcomes (2)

• Palatal itching score

  day 1 and day 7

• Efficacy and tolerability assessment by the patients

  day1 and day 7

Study Arms (2)

Azelastine group

Azelastine nasal spray Azelastine eye drops

Ectoin group

Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops

Eligibility Criteria

• Age: 18 Years - 70 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:

• 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

You may not qualify if:

• 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

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: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

DE (1)