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NCT00389363 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00389363
Other study ID # MT-02
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 17, 2006
Last updated August 16, 2010
Start date August 2006
Est. completion date April 2008

Study information
Verified date August 2010
Source ALK-Abelló A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyItaly: The Italian Medicines AgencyPoland: Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Paul-Ehrlich-InstitutFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 14 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ALK HDM tablet

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Use of inhaled corticosteroid (ICS).
Secondary Use of rescue medication and symptoms.
Secondary Quality of Life.
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