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Completed

NCT Number: NCT00540150

Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy

We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.

Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.

Completed

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Key information

Conditions

Immunotherapy Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

About this study

see above

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • informed consent of patient and/or parents
  • age >6 and <18 years
  • bronchial asthma I° or II°
  • allergy on house dust-mite

Exclusion criteria

  • age <6 and >18 years
  • vital capacity <80% or FEV1 <70%
  • pregnancy
  • inhalative or systemic steroid use
  • bronchial asthma III° or IV°
  • heavy exacerbation during the last 3 months

Treatment and study plan

specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)

Biological

We treat each patient with mite-allergen following the two different protocols.

Other names: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany

Primary outcomes

  1. Safety of the shortened specific immunotherapy.

    Time frame: may 2004 - march 2005

Secondary outcomes

  1. Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.

    Time frame: may 2004 - march 2005

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Collaborators

  • Allergopharma GmbH & Co. KG

Registry information

Official study title

Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.

Important dates

Study start
2004
Study completion
2005
First posted
Oct 5, 2007
Registry last updated
Oct 5, 2007

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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