Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492076
• Other study ID #: E04/05/PP-M
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2007
• Last updated: October 15, 2008
• Start date: October 2006
• Est. completion date: May 2008

Study information

• Verified date: October 2008
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Biological:
• Pangramin Plus D. pteronyssinus 100%
Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo

Locations

Country	Name	City	State
Spain	Hospital Virgen del Camino, Allergology Service	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in inhaled corticosteroids		4 months	No
Secondary	Reduction in symptoms and rescue medication Tolerability		4 months	Yes