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Efficacy and Safety Trial of the ALK HDM Tablet in House Dust Mite Allergic Subjects

Phase 2
Completed
Conditions
Asthma
Registration Number
NCT00389363
Lead Sponsor
ALK-Abelló A/S
Brief Summary

The purpose of the trial is to determine if treatment of asthma patients allergic to house dust mites with the ALK HDM tablet can reduce the need of inhaled corticosteroids (ICS).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
800
Inclusion Criteria
  • A history of house dust mite induced asthma
  • Use of inhaled corticosteroids (ICS)
  • Positive skin prick test to house dust mites
  • Positive specific IgE to house dust mites
Exclusion Criteria
  • FEV1 lower than 70%

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Use of inhaled corticosteroid (ICS).
Secondary Outcome Measures
NameTimeMethod
Use of rescue medication and symptoms.
Quality of Life.

Trial Locations

Locations (1)

Rigshospitalet

🇩🇰

Copenhagen, Denmark

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