Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma - Full Text View

Sponsored by:	ALK-Abelló A/S
Information provided by:	ALK-Abelló A/S
ClinicalTrials.gov Identifier:	NCT00492076

Purpose

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.

Condition	Intervention	Phase
Allergic Asthma	Biological: Pangramin Plus D. pteronyssinus 100%	Phase IV

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:

Reduction in inhaled corticosteroids [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in symptoms and rescue medication Tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	October 2006
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pangramin Plus Dermatophagoides pteronyssinus 100%	Biological: Pangramin Plus D. pteronyssinus 100% Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo
2: Placebo Comparator Pangramin Plus placebo	Biological: Pangramin Plus D. pteronyssinus 100% Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo

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.

Eligibility

Ages Eligible for Study:	14 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492076

Locations

Spain, Navarra
Hospital Virgen del Camino, Allergology Service
Pamplona, Navarra, Spain, 31002

Sponsors and Collaborators

ALK-Abelló A/S

Investigators

Principal Investigator:

Ana I Tabar, MD PhD

Hospital Virgen del Camino

More Information

No publications provided

Responsible Party:	ALK-ABELLO, S.A. ( Fernando de la Torre/medical marketing manager )
Study ID Numbers:	E04/05/PP-M
Study First Received:	June 26, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00492076 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by ALK-Abelló A/S:

Specific immunotherapy
Mite
Asthma

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009