Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Asthma Clinical Trial

Official title:

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501527
• Other study ID #: 2006-001437-18
• Secondary ID: 6078-PG-OSL-145
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2007
• Last updated: December 16, 2010
• Start date: September 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2010
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Immunotherapy with modified extract of P. pratense pollen
Sublingual (2 drops daily)

Other:
• Placebo
Placebo 2 drops daily

Locations

Country	Name	City	State
Spain	Hospital Clínico de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom scores		1 year	No
Secondary	Nasal provocation test		1 year	No
Secondary	Dose-response skin prick-test		1 year	No
Secondary	Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)		1 year	No
Secondary	Medication scores		1 year	No
Secondary	Visual scales		1 year	No
Secondary	"In vitro" immunological tests		1 year	No
Secondary	Record of adverse events		1 year	Yes