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OpenTrials
Completed

NCT Number: NCT02131038

Application of Ectoine Nasal Spray in Comparison With Cromolyn Sodium Containing Nasal Spray 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. 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.

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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 and older

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

  • 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

Treatment and study plan

Medica device, drug-like

Other

Ectoin (R) Allergy Nasal Spray

Primary outcomes

  1. Change in combined nasal symptom Score

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

    The change in the sum of the three different parameters nasal congestion, rhinorrhea and nasal errhine were investigated as combined score.

Secondary outcomes

  1. Patient's and physician's judgment of efficacy

    Time frame: Day 7 and 14

    Patient and physician were asked to grade the efficacy of the treatment on a scale from 0 to 8.

  2. Eye itching score,

    Time frame: Day 1, 7, 14

  3. Epiphora score

    Time frame: Day1, Day 7 and Day 14

  4. Conjunctivitis score,

    Time frame: Day 1, Day 7 Day 10

  5. Palatal itching score

    Time frame: Day 1, Day 7, Day 14

  6. Nasal muscle hyperplasia score

    Time frame: Day 1, Day 7 and Day 14

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 6, 2014
Registry last updated
Jan 29, 2026

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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