Clinical trial NCT00501527: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Asthma
Keywords: Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis
Asthma
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Symptom scores
timeFrame: 1 year
Secondary outcomes:
measure: Nasal provocation test
timeFrame: 1 year
measure: Dose-response skin prick-test
timeFrame: 1 year
measure: Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)
timeFrame: 1 year
measure: Medication scores
timeFrame: 1 year
measure: Visual scales
timeFrame: 1 year
measure: "In vitro" immunological tests
timeFrame: 1 year
measure: Record of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
Study officials:
name: Félix Lorente, Prf. PhD
role: PRINCIPAL_INVESTIGATOR
References: