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Twin SUBLIVAC® Grasses Clinical Efficacy Study

2014-07-24 14:23:01 | BioPortfolio

Summary

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.

Description

Indication under study: IgE mediated allergic disorders triggered by grass pollen.

Number of centres: approximately 50.

Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season.

Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 > 70%) related to grass pollen, age 12 years or older.

Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached.

Route of administration: Sublingual application (drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed).

Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Rhinitis, Allergic, Seasonal

Intervention

SUBLIVAC® Grasses/Placebo treatment, SUBLIVAC® Grasses treatment, Placebo treatment

Location

Dr. P. van Durme
Antwerp
Belgium
2020

Status

Completed

Source

HAL Allergy

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:23:01-0400

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Medical and Biotech [MESH] Definitions

A large family of narrow-leaved herbaceous grasses of the order Cyperales, subclass Commelinidae, class Liliopsida (monocotyledons). Food grains (CEREALS) come from members of this family. RHINITIS, ALLERGIC, SEASONAL can be induced by POLLEN of many of the grasses.

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A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Seeds from grasses (POACEAE) which are important in the diet.

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