Trial document




drksid header

  DRKS00004312

Trial Description

start of 1:1-Block title

Title

Efficacy of gencydo nasal spray on early nasal response after allergen exposition in patients with grass pollen allergy, a randomized, placebo controlled cross over study

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

In a placebo-controlled, double-blinded clinical trial the effectiveness of Gencydo nasal spray in primarily healthy gras pollen allergic patients (18-50 years) will be shown.
Patients will be nasally provoked with grass pollen, the allergic reaction (measured by nasal flow and histamine concentration) after treatment with gencydo and placebo will be compared with the baseline.
In the preclinical trial gencydo showed stabilizing effects on mast cells. This shall be proven in a clinical trial. We expect a smaller allergic reaction after treatment with gencydo in comparison to placebo and no treatment.

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

Brief Summary in Scientific Language

In a placebo-controlled, double-blinded clinical trial the effectiveness of Gencydo nasal spray in primarily healthy gras pollen allergic patients (18-50 years) will be shown.
Patients will be nasally provoked with grass pollen, the allergic reaction (measured by nasal flow and histamine concentration) after treatment with gencydo and placebo will be compared with the baseline.
In the preclinical trial gencydo showed stabilizing effects on mast cells. This shall be proven in a clinical trial. We expect a smaller allergic reaction after treatment with gencydo in comparison to placebo and no treatment.
The different nasal allergic reaction to gras pollen after treatment with gencydo is to be measured and compared quantitavely (rhinomanometry, histamine concentration in nasal lavage fluid).
After treatment with verum we expect an up to 50 % reduced nasal flow reduction in comparison to baseline and placebo. Furthermore we expect a smaller increase of histamine cncentration in nasal lavage fluid after provocation.

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

Organizational Data

  •   DRKS00004312
  •   2012/10/29
  •   [---]*
  •   yes
  •   Approved
  •   320/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1134-7841 
  •   2012-003281-40 
  •   4038487 
  •   [---]* 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J30.1 -  Allergic rhinitis due to pollen
  •   [---]* -  [---]*
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   1. Weleda Pollen Allergy Spray (Gencydo)

    3x daily, 2 sprays each, for 1 week
  •   2. Placebo
    3x daily, 2 sprays each, for 1 week
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   patient/subject, therapist/clinician
  •   Placebo
  •   Treatment
  •   Crossover
  •   II
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

•Rhinomanometrically measured inspiratory nasal flow at 150 Pascal after provocation with grass pollen in an intraindividual comparison between Gencydo and placebo treatment

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

Secondary Outcome

Concentration of histamine in nasal lavage fluid after provocation with grass pollen in an intraindividual comparison between Gencydo and placebo

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/10/29
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

- men and women aged between 18 - 50 years
- symptoms of grass polen allergy for at least 2 years (sneezing, itching of nose, running nose, tears)
- proof of allergy through prick test
- signed consent

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

Exclusion Criteria

• Chronic serious illness (i.e. diabetes mellitus type I, chronic polyarthritis, tumors, heart insufficiency, HIV-Infection)
• Asthma bronchiale with continuous therapy with inhalative or systemic steroides
• Hypersensitivity against compounds of Gencydo (quince, lemon)
• Treatment with Gencydo Nasal Spray within the last month before inclusion into the study
• Therapy with antihistamines, Cromoglycine acid, steroides or other antiallergic medication with 2 weeks before inclusion into the study
• anamnestic alcohol abuse >30g/d or iv. drug abuse
• pregnancy or breat feeding
• simultaneous participation in another clinical study within 3 months before inclusion into the study
• acute infection of airways or allergic reaction with distant symptoms

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • UNiversitätsklinikum Freiburg, Leitender ärztlicher Direktor
    • Mr.  Prof. Dr. Dr. h. c.   Jörg  Sievert 
    • Hugstetterstr. 49
    • 79106  Freiburg
    • Germany
    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
    • Uni-Zentrum Naturheilkunde
    • Mr.  PD Dr.   Roman  Huber 
    • Breisacherstr. 115B
    • 79106  Freiburg
    • Germany
    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
    • Uni-Zentrum Naturheilkunde, so.o.
    • Ms.  Annika  Hoffmann 
    • Guteleutstraße 33
    • 79115  Freiburg
    • Germany
    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
    • Unizentrum Naturheilkunde
    • Mr.  PD  Roman  Huber 
    • Breisacherstraße 115b
    • 79106  Freiburg
    • Germany
    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
  •   2012/12/04
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.