NCT01433523

Brief Summary

The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
834

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Aug 2011

Typical duration for phase_3 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, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

August 26, 2011

Last Update Submit

January 27, 2017

Conditions

Asthma

Keywords

HDMAITasthmaasthma exacerbationHouse dust mite induced asthma

Outcome Measures

Primary Outcomes (1)

  • Time to first moderate or severe asthma exacerbation after ICS reduction

    Measured during the last 6 months of the trial

Secondary Outcomes (6)

  • Difference in changes in immunological parameters (IgE, IgG4)

    Measured at the end of the trial

  • Time to first severe asthma exacerbation after ICS reduction

    Measured during the last 6 months of the trial

  • Frequency of asthma exacerbations following ICS reduction

    Measured during the last 6 months of the trial

  • The average overall symptom score.

    Measured during the last 6 months of the trial

  • Symptom free days

    Measured during the last 6 months of the trial

  • +1 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: ALK HDM AIT Placebo

ALK HDM AIT 6 DU

EXPERIMENTAL
Drug: ALK HDM AIT 6 DU

ALK HDM AIT 12 DU

EXPERIMENTAL
Drug: ALK HDM AIT 12 DU

Interventions

ALK HDM AIT PlaceboDRUG

Oral lyophilisate, Placebo, to be administered sublingually once daily

Placebo
ALK HDM AIT 6 DUDRUG

Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.

ALK HDM AIT 6 DU
ALK HDM AIT 12 DUDRUG

Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.

ALK HDM AIT 12 DU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical relevant history consistent with house dust mite induced asthma of at least 1 year prior to trial entry.
  • Use of an appropriate amount of inhaled corticosteroid for the control of asthma symptoms.
  • Documented reversible airway obstruction.
  • Suitable level of asthma control.
  • FEV1 ≥ 70% of predicted value.
  • Positive Skin Prick Test response to Der pte and/or Der far.
  • Positive specific IgE against Der pte and/or Der far (≥ IgE Class 2; ≥ 0.70 KU/L).

You may not qualify if:

  • A clinical history of persistent allergic asthma or rhinitis caused by an allergen to which the subject is regularly exposed and sensitised (except house dust mites).
  • A clinical history of intermittent allergic asthma or rhinitis if the seasonal allergen is causing symptoms in the period from October to March.
  • Any clinically relevant chronic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6

Rostock, 18057, Germany

Location

Related Publications (2)

  • Hoof I, Bonnelykke K, Stranzl T, Brand S, Li X, Shamji MH, Meyers DA, Bateman ED, Bleecker E, Andersen PS. Genetic and T2 biomarkers linked to the efficacy of HDM sublingual immunotherapy in asthma. Thorax. 2024 Mar 15;79(4):332-339. doi: 10.1136/thorax-2023-220707.

    PMID: 38160049DERIVED

  • Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.

    PMID: 32926419DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christian Virchow, Prof.Dr.med.

    Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

September 14, 2011

Study Start

August 1, 2011

Primary Completion

April 1, 2013

Study Completion

February 1, 2014

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

DE(1)