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

NCT00550875 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-07-13

No results posted yet for this study

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.

Conditions

  • Allergic Rhinoconjunctivitis

Interventions

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

Sponsors & Collaborators

  • Laboratorios Leti, S.L.

    lead INDUSTRY

Principal Investigators

  • Paul Potter, PhD, Prof. · UCT Lung Institute, Cape Town, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00550875 on ClinicalTrials.gov