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

Allergic Rhinoconjunctivitis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550875
• Other study ID #: 6078-PG-OSL-137
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2007
• Last updated: July 12, 2011
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of HealthSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics Council
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• Grass pollen allergenic extract (L. perenne-C. dactylon )
Sublingual. 2 drops/daily 1000 DPP/ml 2 years
• Grass pollen allergenic extract (L. perenne-C. dactylon )
Sublingual. 2 drops/daily 10000 DPP/ml 2 years
• placebo
Sublingual. 2 drops/daily 2 years

Locations

Country	Name	City	State
South Africa	Allergy Unit, UCT Lung Institute	Mowbray	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC for Symptom Score and Mean Symptom Score in the pollen period.		2 years	Yes
Secondary	Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events		2 years	Yes