NCT00540631

Brief Summary

Multicenter Immunotherapy House Dust Mite Allergoid

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

October 5, 2007

Last Update Submit

February 8, 2013

Conditions

Rhinoconjunctivitis

Keywords

House Dust Mite AllergenAluminium hydroxide-adsorbed

Outcome Measures

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

    November 2007 - February 2010

Secondary Outcomes (4)

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

    1 year

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

    2 years

  • Immunologic changes IgE, IgG1 and IgG4

    2 years

  • Tolerability and safety of treatments during the entire study period

    4 years

Study Arms (2)

P

NO INTERVENTION

subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals

A

EXPERIMENTAL

Active treatment with house dust mite extract

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

Interventions

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 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 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 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued

A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

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

Location

Related Links

Study Officials

  • Herbert Riechelmann, MD

    University Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 8, 2007

Study Start

October 1, 2007

Primary Completion

August 1, 2010

Study Completion

December 1, 2011

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

DE(1)