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Completed

NCT Number: NCT00501527

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapy with modified extract of P. pratense pollen

Biological

Sublingual (2 drops daily)

Placebo

Other

Placebo 2 drops daily

Primary outcomes

  1. Symptom scores

    Time frame: 1 year

Secondary outcomes

  1. Nasal provocation test

    Time frame: 1 year

  2. Dose-response skin prick-test

    Time frame: 1 year

  3. Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ)

    Time frame: 1 year

  4. Medication scores

    Time frame: 1 year

  5. Visual scales

    Time frame: 1 year

  6. "In vitro" immunological tests

    Time frame: 1 year

  7. Record of adverse events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Laboratorios Leti, S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2007
Registry last updated
Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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