CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 124 enrolled
Drug / intervention
SLITone(TM) Dermatophagoides mix +6 morebiological
Likely dose
Salbutamol inhaler 200 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00633919
NCT00633919Phase 3Completed
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A Randomised, Double-blind, Placebo-controlled Trial Assessing the Efficacy of SLITone in House Dust Mite Allergic Patients

ALK-Abelló A/S·interventional·Posted Mar 12, 2008·Updated Jun 8, 2011

In Brief

A Phase 3 clinical trial evaluating SLITone(TM) Dermatophagoides mix, Placebo, and 5 other interventions for Allergy. Completed, enrolled 124 participants across 1 site.

Detailed Summary

This trial has been designed to evaluate the efficacy of specific immunotherapy with SLITone Dermatophagoides mix compared with placebo in subjects with house dust mite allergic asthma, based on asthma medication use during a period of 2 months with a high environmental exposure to mites (autumn 2008).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergy
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2008
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.3 years ago

Interventions

SLITone(TM) Dermatophagoides mixbiological

Sublingual immunotherapy with SLITone Dermatophagoides mix (200 STU) once daily for 2 years

Placebobiological

Sublingual immunotherapy once daily for 2 years

Salbutamol inhalerdrug

200 µg per puff; a short acting beta2-agonist (please refer to the 'detailed description' for details on the use)

Budesonide/formoterol inhalerdrug

80/4.5 µg per inhalation; a combination of inhaled corticosteroids and long acting beta2-agonist (please refer to the 'detailed description' for details on the use)

Prednisone tabletdrug

5 mg per tablet; oral corticosteroids (please refer to the 'detailed description' for details on the use)

Desloratadine tabletdrug

5 mg per tablet: anti-histamine (please refer to the 'detailed description' for details on the use)

Budesonide nasal spraydrug

64 µg per puff; inhaled corticosteroid (please refer to the 'detailed description' for details on the use)