Clinical trial NCT00550875: Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergic rhinoconjunctivitis,
Immunotherapy
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: AUC for Symptom Score and Mean Symptom Score in the pollen period.
timeFrame: 2 years
Secondary outcomes:
measure: Symptom Score, Immunological evaluation,Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Mowbray
country: South Africa
facility: Allergy Unit, UCT Lung Institute
state: Cape Town
Study officials:
affiliation: UCT Lung Institute, Cape Town, South Africa
name: Paul Potter, PhD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: