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Completed

NCT Number: NCT02133053

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

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.

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Key information

Conditions

Allergic Rhinitis 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed allergic rhinitis during the observational period

Exclusion criteria

  • Contra indications according to the label

Treatment and study plan

Medical device, drug-like

Other

Ectoin Allergy Nasal Spray

Beclomethasone

Drug

Beclomethasone nasal spray

Primary outcomes

  1. Change in Total Nasal Symptom Score

    Time frame: Time Frame: day 1, day 7, day 14

Secondary outcomes

  1. Change in palatal itching score

    Time frame: Day 1, 7 and 14

  2. Efficacy and tolerability assessment by the patients and by the investigator

    Time frame: day 7 and 14

  3. Change in quality of life assessed by Rhinitis Quality of Life Questionnaire

    Time frame: Day1 and Day 14

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 7, 2014
Registry last updated
May 7, 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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