Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

A Randomised, Double-Blind Placebo-Controlled Study Assessing the Short-Term Effect of a Dermatophagoides Pteronyssinus Extract, Quantified in Mass Units, in Subjects With Perennial Mite Induced Asthma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00492076

Enrollment

Registered

2007-06-27

Start date

2006-10-31

Completion date

2008-05-31

Last updated

2008-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma

Keywords

Specific immunotherapy, Mite, Asthma

Brief summary

The purpose of this study is to determine whether a short course of subcutaneous immunotherapy is efficacious in mite induced asthma. The efficacy is based on reduction in control medication.

Detailed description

The control of mild-moderate persistent asthma include the need of concomitant medication, as inhaled corticosteroids. However, compliance in perennial asthma is low. The aim of this study is to assess the possibility to reduce the need of concomitant medication through a short-course of subcutaneous immunotherapy.

Interventions

BIOLOGICALPangramin Plus D. pteronyssinus 100%

1. Active. Pangramin Plus D. pteronyssinus 100% 2. Placebo. Pangramin Plus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

14 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Mild/moderate persistent asthma * Positive skin prick test or specific IgE to mites * Age: 14-55 years old

Exclusion criteria

* Immunotherapy contraindications * Allergy to other inhalant allergens * Previous immunotherapy (5 years)with mites

Design outcomes

Primary

Measure	Time frame
Reduction in inhaled corticosteroids	4 months

Secondary

Measure	Time frame
Reduction in symptoms and rescue medication Tolerability	4 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026