Pilot study on asthma control in patients with grass- pollen allergic rhinitis treated with 5 grass-pollen sublingual immunotherapy (Staloral®) vs placebo - 5GRAPS

Dr. Javier Domínguez Ortega0 sitesMarch 3, 2015

ConditionsRespiratory Allergy: Asthma and allergic rhinitis due to grass pollen Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

DrugsStaloral Pollens maintenance 300 IR/ml sublingual solution

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Allergy: Asthma and allergic rhinitis due to grass pollen
Sponsor: Dr. Javier Domínguez Ortega
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 3, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Dr. Javier Domínguez Ortega

Eligibility Criteria

Inclusion Criteria

•?Patients of both sexes aged at 12 years of age or over.
•?Patients with rhinitis or allergic rhino\-conjunctivitis who, moreover, suffer asthma due to grass?pollen allergy and present clinical manifestations of asthma during grass\-pollen pollination periods (May to July).
•?Patients who have had persistent rhinitis of moderate or severe intensity during the past year, according to the ARIA classification modified by Valero et al.11
•?Patients with a clinical diagnosis of allergic respiratory disease, asthma and rhinitis or rhino\-conjunctivitis, of at least two years evolution.
•?Patients with persistent, mild or moderate allergic asthma (GEMA 2009 guide), in which an etiological relation is established with allergy to grass\-pollen and clinical manifestations of purely seasonal asthma in grass\-pollen pollination periods in Madrid (May to July)
•?Patients with a CASI index of ? 6 points during the last grass\-pollen pollination peak (May\-June 2015\).
•?Patients with FEV1 ? 60% during the last grass\-pollen pollination peak (May\-June 2015\).
•?Sensitization to grass\-pollens, detected by prick test (wheal greater than 3 mm diameter on average) using standardized extracts. A prick test of no more than one year old will be accepted as valid at the time of study patient inclusion.
•?Levels of specific IgE antibodies against main grass\-pollen allergens (Phl p 1\) ? 17\.5 U/ml (class 4 RAST). Laboratory tests of no more than one year old will be accepted as valid at the time of study patient inclusion.
•?Patients eligible for treatment with allergen immunotherapy who have not received such since February 2011\.

Exclusion Criteria

•?Patients with persistent asthma outside grass\-pollen pollination periods.
•?Patients with intermittent asthma due to another allergen different from grass\-pollens while presenting symptoms between the 15th of March and the 15th of August.
•?Patients with rhinitis and /or rhino\-conjunctivitis due to another allergen different from grass\-pollens while presenting symptoms between the 15th of March and the 15th of August.
•?Patients with allergy symptoms of perennial allergens.
•?Patients who have had asthmatic crises outside the grass\-pollen season during the last 3 years (since May 2012\)
•?Patients who smoke or are ex\-smokers or do not wish to abstain from smoking during the period that the study lasts (3 years).
•?Patients with other pulmonary diseases different from asthma.
•?Patients with FEV1 \< 60% at the time of screening.
•?Patients with severe asthma.
•?Patients with other nasal diseases different from allergic rhinitis.