NCT00622362

Brief Summary

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract Dermatophagoides pteronyssinus in children with allergic asthma due to this mite

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

January 10, 2008

Last Update Submit

March 6, 2019

Conditions

Allergic Asthma

Keywords

ImmunotherapyAllergyAllergoidDepigmentedPolymerizedAllergen-extractmitesAsthma

Outcome Measures

Primary Outcomes (1)

  • Symptom and medication scores

    1 year per patient

Secondary Outcomes (6)

  • Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources

    1 year per patient

  • QoL

    1 year

  • Cost-effectiveness

    1 year

  • Dose response prick-test

    1 year

  • Inflammatory markers

    1 year

  • +1 more secondary outcomes

Study Arms (3)

A

ACTIVE COMPARATOR

Subcutaneous administration

Biological: DEPIGOID Dermatophagoides pteronyssinus

B

EXPERIMENTAL

Sublingual administration

Biological: Polymerized TOL of Dermatophagoides pteronyssinus

C

PLACEBO COMPARATOR

Sublingual administration

Biological: Placebo Comparator

Interventions

DEPIGOID Dermatophagoides pteronyssinusBIOLOGICAL

Subcutaneous administration:0.5 ml/month during 1 year

A
Polymerized TOL of Dermatophagoides pteronyssinusBIOLOGICAL

Sublingual immunotherapy. Two drops daily during 1 year

B
Placebo ComparatorBIOLOGICAL

Sublingual immunotherapy. Two drops daily during 1 year

C

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Written informed consent signed by the patient and guardian.
  • Positive clinical history of allergy to dust mites.
  • FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
  • Age-between 5 and 14 years.
  • Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size \> 3 mm diameter and / or RAST (\> 0.7 kU / L).

You may not qualify if:

  • Patients out of the age range.
  • Use of immunotherapy during the last four years.
  • Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
  • Treatment with ß-blockers
  • Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..).
  • Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
  • Patients suffering from immune deficiencies
  • Patients with serious psychiatric / psychological disturbances
  • Patients aspirin intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Fé

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

HypersensitivityAsthma

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Study Officials

  • Antonio Nieto, MD PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2008

First Posted

February 25, 2008

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

ES(1)