NCT00263640

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Allergopharma GmbH & Co. KG · Industry
• Sex: All
• Age: 6 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	Placebo	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.

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-04-01
• Completion: 2012-08-01
• First posted: 2005-12-09
• Last updated: 2015-01-15

Locations

1 site across 1 country: Germany