NCT00389363

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started Aug 2006

Typical duration for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 17, 2010

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

October 17, 2006

Last Update Submit

August 16, 2010

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Use of inhaled corticosteroid (ICS).

Secondary Outcomes (2)

  • Use of rescue medication and symptoms.

  • Quality of Life.

Interventions

ALK HDM tabletDRUG

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • FEV1 lower than 70%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.

    PMID: 29656145DERIVED

  • Mosbech H, Canonica GW, Backer V, de Blay F, Klimek L, Broge L, Ljorring C. SQ house dust mite sublingually administered immunotherapy tablet (ALK) improves allergic rhinitis in patients with house dust mite allergic asthma and rhinitis symptoms. Ann Allergy Asthma Immunol. 2015 Feb;114(2):134-40. doi: 10.1016/j.anai.2014.11.015.

    PMID: 25624131DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kim Simonsen, MD.

    ALK-Abelló

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

August 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 17, 2010

Record last verified: 2010-08

Locations

DK(1)