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

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.

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Key information

Conditions

Allergic Rhinoconjunctivitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HNO Praxis Elmshorn

Elmshorn, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Change in primary allergic symptoms symptoms

Time frame: Day1, Day 7

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)

Secondary outcomes

Palatal itching score

Time frame: day 1 and day 7
Efficacy and tolerability assessment by the patients

Time frame: day1 and day 7

Patients assess the efficacy and tolerability separately based on a general an Scale from 0 to 8

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: May 6, 2014
Registry last updated: May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed