MedTrace Logo

Efficacy of SLITone in House Dust Mite Allergic Patients

NCT00633919 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2011-06-08

Study results available
· View outcomes & findings →

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).

Conditions

  • Allergy

Interventions

BIOLOGICAL

SLITone(TM) Dermatophagoides mix

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

BIOLOGICAL

Placebo

Sublingual immunotherapy once daily for 2 years

DRUG

Salbutamol inhaler

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

DRUG

Budesonide/formoterol inhaler

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)

DRUG

Prednisone tablet

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

DRUG

Desloratadine tablet

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

DRUG

Budesonide nasal spray

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

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Santiago Martín, PhD · Clinical Research Director, ALK-Abelló, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633919 on ClinicalTrials.gov