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Completed

NCT Number: NCT00540631

Multicenter Trial of Immunotherapy With House Dust Mite Allergoid

Multicenter Immunotherapy House Dust Mite Allergoid

Completed

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Key information

Conditions

Rhinoconjunctivitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

About this study

A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

Exclusion criteria

  • Serious chronic diseases
  • other perennial allergies

Treatment and study plan

specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)

Biological

Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection

  • to be det. A 0.1 100 TU
  • 7 (+7) days later A 0.2 200 TU
  • 7 (+7) days later A 0.4 400 TU
  • 7 (+7) days later A 0.6 600 TU
  • 7 (+7) days later B 0.1 1000 TU
  • 7 (+7) days later B 0.2 2000 TU
  • 7 (+7) days later B 0.4 4000 TU
  • 7 (+7) days later B 0.6 6000 TU

Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection

  • to be det. A 0.1 100 TU
  • 7 (+7) days later A 0.2 200 TU
  • 7 (+7) days later A 0.4 400 TU
  • 7 (+7) days later A 0.6 600 TU
  • 7 (+7) days later B 0.1 1000 TU
  • 7 (+7) days later B 0.2 2000 TU
  • 7 (+7) days later B 0.4 4000 TU
  • 7 (+7) days later B 0.6 6000 TU

Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued

Primary outcomes

  1. The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline

    Time frame: November 2007 - February 2010

Secondary outcomes

  1. Change of the AUC of the SMS after one year to baseline.

    Time frame: 1 year

  2. Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline

    Time frame: 2 years

  3. Immunologic changes IgE, IgG1 and IgG4

    Time frame: 2 years

  4. Tolerability and safety of treatments during the entire study period

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study title

A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale

Acronym: ACRI

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Oct 8, 2007
Registry last updated
Feb 11, 2013

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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