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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02131038
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):
Bitop AG

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.

Condition or disease Intervention/treatment
Allergic Rhinitis Other: Medica device, drug-like

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non Interventional, Open Label Trial of Ectoine Containing Nasal Spray in Comparison With Cromoglycic Acid Containing Nasal Spray in Patients With Allergic Rhinitis
Study Start Date : May 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Ectoin group
Ectoin Allergy Nasal Spray
Other: Medica device, drug-like
Ectoin (R) Allergy Nasal Spray

Cromolyn group
Cromolyn sodium

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02131038

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HNO Praxis Elmshorn
Elmshorn, Germany
Sponsors and Collaborators
Bitop AG
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Principal Investigator: Uwe Sonnemann, MD HNO Praxis Elmshorn

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Responsible Party: Bitop AG Identifier: NCT02131038    
Other Study ID Numbers: Rep-25
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Bitop AG:
Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases