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

A Phase II-III Trial Assessing the Efficacy and Safety of Three Doses of the ALK HDM Tablet in House Dust Mite Allergic Patients

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389363

Enrollment

800

Registered

2006-10-18

Start date

2006-08-31

Completion date

2008-04-30

Last updated

2010-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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).

Interventions

DRUGALK HDM tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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%

Design outcomes

Primary

Measure	Time frame
Use of inhaled corticosteroid (ICS).	—

Secondary

Measure	Time frame
Use of rescue medication and symptoms.	—
Quality of Life.	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026