Efficacy and Safety Trial of Subcutaneous Immunotherapy i... | NCT00492076

Studies
Efficacy and Safety Trial of Subcutaneous Immunotherapy in Mite Induced Asthma

NCT00492076

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

Oct 16, 2008Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Allergic Asthma

Interventions

Pangramin Plus D. pteronyssinus 100%

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jun 26, 2007

First Submission Date that Met QC Criteria

Jun 26, 2007

First Posted Date

Jun 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2008

Last Update Posted Date

Oct 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Pangramin Plus Dermatophagoides pteronyssinus 100%	Biological: Pangramin Plus D. pteronyssinus 100%
2	Placebo Comparator	Pangramin Plus placebo	Biological: Pangramin Plus D. pteronyssinus 100%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pangramin Plus D. pteronyssinus 100%	Biological	Active. Pangramin Plus D. pteronyssinus 100% Placebo. Pangramin Plus placebo	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in inhaled corticosteroids		4 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in symptoms and rescue medication Tolerability		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ana I Tabar, MD PhD	Hospital Virgen del Camino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Virgen del Camino, Allergology Service		Pamplona	Navarre	31002	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided