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Completed

NCT Number: NCT00389363

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

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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

ALK HDM tablet

Drug

Primary outcomes

  1. Use of inhaled corticosteroid (ICS).

Secondary outcomes

  1. Use of rescue medication and symptoms.

  2. Quality of Life.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2006
Registry last updated
Aug 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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