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Completed

NCT Number: NCT00263640

Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma

The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.

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Key information

Conditions

Respiratory Hypersensitivity Asthma Bronchial Diseases Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

About this study

The rationale for the present study was to demonstrate clinical efficacy and tolerability compared to placebo in a phase III clinical study of pivotal character with a representative number of patients suffering from fully reversible asthma +/- allergic rhinitis. This condition is present in paediatric and adult patients with a shorter history of GINA II and III asthma, who were investigated in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bronchial asthma
  • Requirements for inhaled corticosteroid
  • Positive skin prick test to house dust mite
  • Positive radioallergosorbent test (RAST) to house dust mite
  • Positive provocation test result to house dust mite

Exclusion criteria

  • Serious chronic diseases
  • Other perennial allergies

Treatment and study plan

Acaroid

Biological

The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.

Other names: Specific Immunotherapy

Placebo

Drug

Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.

Other names: Comparator

Primary outcomes

  1. Inhalative dose of fluticasone propionate

    Time frame: After 2 years

    The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.

Secondary outcomes

  1. Pre-bronchodilator morning peak flow

    Time frame: After 2 years

    Post treatment, the changes from baseline in the mean pre-bronchodilator morning peak flow during the last two weeks of the diary phases were determined.

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study title

A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Alum.-Adsorbed Allergoid Preparation of House Dust Mite (D. Pteronyssinus) in Patients With Allergic Bronchial Asthma, Rhinitis, Rhinoconjunctivitis

Important dates

Study start
2005
Primary completion
2009
Study completion
2012
First posted
Dec 9, 2005
Registry last updated
Jan 15, 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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