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

NCT ID: NCT00389363

Last Updated: 2010-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ALK HDM tablet

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ALK-Abelló A/S

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kim Simonsen, MD.

Role: STUDY_DIRECTOR

ALK-Abelló

Locations

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Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 29656145 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25624131 (View on PubMed)

Other Identifiers

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MT-02

Identifier Type: -

Identifier Source: org_study_id

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