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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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

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Allergic Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Grass pollen allergenic extract (L. perenne-C. dactylon )

Intervention Type BIOLOGICAL

Sublingual. 2 drops/daily 1000 DPP/ml 2 years

2

10\* concentration of arm 1

Group Type EXPERIMENTAL

Grass pollen allergenic extract (L. perenne-C. dactylon )

Intervention Type BIOLOGICAL

Sublingual. 2 drops/daily 10000 DPP/ml 2 years

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BIOLOGICAL

Sublingual. 2 drops/daily 2 years

Interventions

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Grass pollen allergenic extract (L. perenne-C. dactylon )

Sublingual. 2 drops/daily 1000 DPP/ml 2 years

Intervention Type BIOLOGICAL

Grass pollen allergenic extract (L. perenne-C. dactylon )

Sublingual. 2 drops/daily 10000 DPP/ml 2 years

Intervention Type BIOLOGICAL

placebo

Sublingual. 2 drops/daily 2 years

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No