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

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.

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Biological: placebo

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• South Africa
  • Cape Town
    • Mowbray, Cape Town, South Africa, 7700
      • Allergy Unit, UCT Lung Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Sublingual. 2 drops/daily 1000 DPP/ml 2 years; Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Sublingual. 2 drops/daily 10000 DPP/ml 2 years
Placebo Comparator: 3	Biological: placebo; Sublingual. 2 drops/daily 2 years
Experimental: 2; 10* concentration of arm 1	Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Sublingual. 2 drops/daily 1000 DPP/ml 2 years; Biological: Grass pollen allergenic extract (L. perenne-C. dactylon ); Sublingual. 2 drops/daily 10000 DPP/ml 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC for Symptom Score and Mean Symptom Score in the pollen period.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events	2 years

Collaborators and Investigators

• Sponsor: Laboratorios Leti, S.L.
• Investigators: Principal Investigator: Paul Potter, PhD, Prof., UCT Lung Institute, Cape Town, South Africa

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 22, 2007
• First Submitted That Met QC Criteria: October 29, 2007
• First Posted (Estimate): October 30, 2007

Study Record Updates

• Last Update Posted (Estimate): July 13, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Immunotherapy; Allergic rhinoconjunctivitis,
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 6078-PG-OSL-137