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

Phase 3

Completed

• Conditions: Respiratory Hypersensitivity
• Interventions: Drug: Placebo; Biological: Acaroid

• Registration Number: NCT00263640
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-09
• Primary Completion: 2009-04
• Study Completion: 2012-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.
Acaroid	Acaroid	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.

Primary Outcome Measures

Name	Time	Method
Inhalative dose of fluticasone propionate	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 Outcome Measures

Name	Time	Method
Pre-bronchodilator morning peak flow	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.

Trial Locations

Locations (1)

Allergopharma GmbH & Co. KG; 🇩🇪 Reinbek, Germany