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
2 other identifiers
interventional
130
1 country
1
Brief Summary
The trial is performed to assess efficacy and safety of the Allergopharma house dust mite allergoid in bronchial asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2005
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 8, 2005
CompletedFirst Posted
Study publicly available on registry
December 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedJanuary 15, 2015
January 1, 2015
3.9 years
December 8, 2005
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Pre-bronchodilator morning peak flow
After 2 years
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo was given the same way as a subcutaneous (just under the skin) injection. Children received lifestyle counselling.
Acaroid
EXPERIMENTALThe drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Serious chronic diseases
- Other perennial allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allergopharma GmbH & Co. KG
Reinbek, 21465, Germany
Related 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.
PMID: 20624650RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annemie Narkus, M.D.
Allergopharma GmbH & Co. KG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2005
First Posted
December 9, 2005
Study Start
May 1, 2005
Primary Completion
April 1, 2009
Study Completion
August 1, 2012
Last Updated
January 15, 2015
Record last verified: 2015-01