NCT00550875

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Laboratorios Leti, S.L. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
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
BIOLOGICAL	placebo	Sublingual. 2 drops/daily 2 years

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-10-30
• Last updated: 2011-07-13

Locations

1 site across 1 country: South Africa