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Completed

NCT Number: NCT00841256

Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children

Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinik für Paediatrie Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

About this study

Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.

Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.

In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4 - <12 years (at the time of inclusion)
  • Positive SPT
  • Positive EAST
  • Positive CPT

Exclusion criteria

  • Serious chronic diseases
  • Other perennial allergies

Treatment and study plan

Grass pollen allergens in a water/glycerol solution

Biological

In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.

Other names: Allerslit forte grasses

Placebo

Drug

Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.

Other names: Comparator

Primary outcomes

  1. Changes of Symptom-Medication-Score

    Time frame: After 1 year of treatment

    The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.

Secondary outcomes

  1. Evaluation of the documentation of adverse events (AEs)

    Time frame: Entire treatment period

    Safety of treatments during the entire treatment period.

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study title

... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo

Important dates

Study start
2008
Primary completion
2012
Study completion
2015
First posted
Feb 11, 2009
Registry last updated
Oct 16, 2015

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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