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

Respiratory Hypersensitivity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263640
• Other study ID #: Al0104av
• Secondary ID: 2004-003892-35
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2005
• Last updated: January 14, 2015
• Start date: May 2005
• Est. completion date: August 2012

Study information

• Verified date: January 2015
• Source: Allergopharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Hypersensitivity
• Respiratory Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Germany	Allergopharma GmbH & Co. KG	Reinbek

Sponsors (1)

Lead Sponsor	Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: a randomized controlled trial. J Allergy Clin Immunol. 2010 Nov;126(5):942-9. doi: 10.1016/j.jaci.2010.06.002. Epub 2010 Jul 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhalative dose of fluticasone propionate	The primary endpoint variate was the change of inhalative dose of fluticasone propionate needed to ensure asthma control according to GINA recommendation.	After 2 years	No
Secondary	Pre-bronchodilator morning peak flow	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.	After 2 years	No

External Links

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