NCT00501527

Brief Summary

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 17, 2010

Status Verified

December 1, 2010

Enrollment Period

2.1 years

First QC Date

July 13, 2007

Last Update Submit

December 16, 2010

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, AllergicAsthma

Keywords

AllergoidDepigmentedPolymerizedAllergen-extractRhinoconjunctivitisAsthma

Outcome Measures

Primary Outcomes (1)

  • Symptom scores

    1 year

Secondary Outcomes (7)

  • Nasal provocation test

    1 year

  • Dose-response skin prick-test

    1 year

  • Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)

    1 year

  • Medication scores

    1 year

  • Visual scales

    1 year

  • +2 more secondary outcomes

Study Arms (3)

A: Biological vaccine

EXPERIMENTAL

The first active arm will receive a dose that is 10x less than the dose of the other arm

Biological: Immunotherapy with modified extract of P. pratense pollen

B: biological vaccine

EXPERIMENTAL

The first active arm will receive a dose that is 10x more than the dose of the other arm

Biological: Immunotherapy with modified extract of P. pratense pollen

C

PLACEBO COMPARATOR
Other: Placebo

Interventions

Immunotherapy with modified extract of P. pratense pollenBIOLOGICAL

Sublingual (2 drops daily)

A: Biological vaccineB: biological vaccine
PlaceboOTHER

Placebo 2 drops daily

C

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Positive clinical history of allergy to Phleum pratense
  • Patients of both gender aged from 12 up to 50 years.
  • Positive prick test to Phleum pratense allergen extracts
  • Specific IgE to Phleum pratense
  • Positive clinical history of allergic rhinoconjunctivitis and/or asthma
  • Written informed consent.

You may not qualify if:

  • 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
  • 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
  • Pregnant or/ in lactation patients
  • Patients aspirin intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, AllergicAsthma

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesConjunctivitisConjunctival DiseasesEye DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Officials

  • Félix Lorente, Prf. 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

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

September 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 17, 2010

Record last verified: 2010-12

Locations

ES(1)