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Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Primary Purpose

Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Immunotherapy with modified extract of P. pratense pollen
Placebo
Sponsored by
Laboratorios Leti, S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Seasonal focused on measuring Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • In addition, the following was considered as exclusion criteria:
  • Pregnant or/ in lactation patients
  • Patients aspirin intolerance

Sites / Locations

  • Hospital Clínico de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A: Biological vaccine

B: biological vaccine

C

Arm Description

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

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

Outcomes

Primary Outcome Measures

Symptom scores

Secondary Outcome Measures

Nasal provocation test
Dose-response skin prick-test
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Medication scores
Visual scales
"In vitro" immunological tests
Record of adverse events

Full Information

First Posted
July 13, 2007
Last Updated
December 16, 2010
Sponsor
Laboratorios Leti, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT00501527
Brief Title
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
Official Title
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratorios Leti, S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma
Keywords
Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A: Biological vaccine
Arm Type
Experimental
Arm Description
The first active arm will receive a dose that is 10x less than the dose of the other arm
Arm Title
B: biological vaccine
Arm Type
Experimental
Arm Description
The first active arm will receive a dose that is 10x more than the dose of the other arm
Arm Title
C
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Immunotherapy with modified extract of P. pratense pollen
Intervention Description
Sublingual (2 drops daily)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 drops daily
Primary Outcome Measure Information:
Title
Symptom scores
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Nasal provocation test
Time Frame
1 year
Title
Dose-response skin prick-test
Time Frame
1 year
Title
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
Time Frame
1 year
Title
Medication scores
Time Frame
1 year
Title
Visual scales
Time Frame
1 year
Title
"In vitro" immunological tests
Time Frame
1 year
Title
Record of adverse events
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 In addition, the following was considered as exclusion criteria: Pregnant or/ in lactation patients Patients aspirin intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Félix Lorente, Prf. PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

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Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

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