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

ALK-Abelló

Status and phase: Completed; Phase 3; Phase 2

Conditions: Asthma

Treatments: Drug: ALK HDM tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00389363

MT-02

Details and patient eligibility

About

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).

Enrollment: 800 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No 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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind