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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Grass pollen allergenic extract (L. perenne-C. dactylon )
Grass pollen allergenic extract (L. perenne-C. dactylon )
placebo
Sponsored by
Laboratorios Leti, S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergic rhinoconjunctivitis,, Immunotherapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy Unit, UCT Lung Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

10* concentration of arm 1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 22, 2007
Last Updated
July 12, 2011
Sponsor
Laboratorios Leti, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT00550875
Brief Title
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis
Acronym
GPIT
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratorios Leti, S.L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
Allergic rhinoconjunctivitis,, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Description
10* concentration of arm 1
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Grass pollen allergenic extract (L. perenne-C. dactylon )
Intervention Description
Sublingual. 2 drops/daily 1000 DPP/ml 2 years
Intervention Type
Biological
Intervention Name(s)
Grass pollen allergenic extract (L. perenne-C. dactylon )
Intervention Description
Sublingual. 2 drops/daily 10000 DPP/ml 2 years
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
Sublingual. 2 drops/daily 2 years
Primary Outcome Measure Information:
Title
AUC for Symptom Score and Mean Symptom Score in the pollen period.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Potter, PhD, Prof.
Organizational Affiliation
UCT Lung Institute, Cape Town, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit, UCT Lung Institute
City
Mowbray
State/Province
Cape Town
ZIP/Postal Code
7700
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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