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Completed

NCT Number: NCT00550875

Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis

As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score, the patient will be asked to fill in a patient diary. This diary will evaluate the week before the patient comes back to receive the treatment. Nose (sneeze, blockage and running), eye (itching, redness and swelling) and chest (breathlessness, wheeze, chest tightness), are scored on a scale from The patient will be instructed to daily assess each one of the symptoms, recording them on an individual symptoms follow-up diary.

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Key information

Conditions

Allergic Rhinoconjunctivitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Allergy Unit, UCT Lung Institute

Mowbray, Cape Town, 7700, South Africa

About this study

The study drug is a sublingual immunotherapy (vaccine) with allergenic extract of grass pollen (Lolium perenne (50%) + Cynodon dactylon (50%)). Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis (itching, sneezing, stuffy nose, runny nose) for many years. In this study it will be used as drops under the tongue. At the beginning of the study, you will be given a card that documents that you are taking part. Please carry this with you at all times, in case treatment is necessary at another location. The drops will be given at two doses. The drops are held under the tongue for 2 minutes prior to swallowing.Sublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis (nasal allergy and allergy of the eyes).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical history of allergic rhinoconjunctivitis and/or asthma due to hypersensitivity to grass mix Lolium perenne and Cynodon dactylon.
  • Male or female subjects between 18 and 50 years old
  • Positive skin tests to Lolium perenne and Cynodon dactylon: the wheal produced by the skin test by means of the prick-test technique must be equal or superior to the wheal produced by the positive control of prick test (histamine 10 mg/ml).
  • Presence of specific IgE to Lolium perenne and Cynodon dactylon (CAP greater than 17.5K u/L).
  • Female subjects must not be sexually active or must be following a medially accepted contraceptive method.
  • Pregnancy test negative

Exclusion criteria

  • Treatment with ß-blocking agents
  • Patients suffering from some pathology in which the adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.)
  • Autoimmune disease (thyroiditis, lupus, etc.)
  • Conditions in which the patient can not offer full co-operation, compliance or those with significant psychiatric disturbance.
  • Intolerance to aspirin.
  • Pregnant women or with pregnancy risk and breast-feeding women

Treatment and study plan

Grass pollen allergenic extract (L. perenne-C. dactylon )

Biological

Sublingual. 2 drops/daily 1000 DPP/ml 2 years

Placebo

Biological

Sublingual. 2 drops/daily 2 years

Primary outcomes

  1. AUC for Symptom Score and Mean Symptom Score in the pollen period.

    Time frame: 2 years

Secondary outcomes

  1. Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Laboratorios Leti, S.L.

Industry

Registry information

Official study title

A Randomised Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Sublingual Immunotherapy With a Depigmented and Polymerized Grass Pollen Extracts in Patients Suffering From Allergic Rhinoconjunctivitis.

Acronym: GPIT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 30, 2007
Registry last updated
Jul 13, 2011

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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