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CompletedNCT02131051Updated May 6, 2014

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

An observational study in Allergic Rhinoconjunctivitis, sponsored by Bitop AG. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-06.

Sponsored by Bitop AG · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
48
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinoconjunctivitis

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Keywords

  • ectoine
  • allergic rhinitis
  • bitop
03

In context

Rhinitis, Allergic

1,042 studies on the registry are indexed under Rhinitis, Allergic; 91 are open to participants now.

This study's enrollment of 48 is below the median of 126 across 158 observational studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Bitop AG is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary Care Clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • Azelastine group

    Azelastine nasal spray Azelastine eye drops

  • Ectoin group

    Ectoin Allergy Nasal Spray Ectoin Allergy Eye Drops

06

What researchers measure

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)

    Time frame: Day1, Day 7

Secondary outcomes

  1. Palatal itching score

    Time frame: day 1 and day 7

  2. Efficacy and tolerability assessment by the patients

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

    Time frame: day1 and day 7

07

Study locations

1 site
  • HNO Praxis Elmshorn
    Elmshorn, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02131051
Lead sponsor
Bitop AG
Responsible party
Sponsor
First posted
May 6, 2014
Start date
Jun 2010
Primary completion
Sep 2010
Completion
Sep 2010
Last update
May 6, 2014

Study contacts

Uwe Sonnemann, MD
principal investigator · HNO Praxis Elmshorn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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