Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00007245

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007245
  •   2015/04/24
  •   2014/04/25
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT02131051  (ClinicalTrials.gov)
  •   REP-85  (Bitop AG)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Allergic Rhinoconjunctivitis
  •   J30.4 -  Allergic rhinitis, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- 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)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2010/06/30
  •   48
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block 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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Bitop AG
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • HNO Praxis Elmshorn
    • Uwe Sonnemann, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • HNO Praxis Elmshorn
    • Uwe Sonnemann, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2010/09/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.