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

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

• Registration Number: EUCTR2014-003204-70-ES
• Lead Sponsor: Dr. Javier Domínguez Ortega

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-03
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.
?Patients who agree to participate in a clinical trial of 3 years duration.
?Patients must voluntarily accept to take part in the study, while understanding the procedures and risks that may derive from it and sign a written informed consent form.
?Patients must be capable of filling out the self-administered patient?s daily record and questionnaires.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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.
?Patients with levels of specific IgE antibodies against major allergens of olive (Ole e 1or whole olive extract) of > 3.5 U / ml (class 3 RAST). Laboratory test results of no more than one year old will be accepted (following the same criteria as that for grass-pollens).
?Women of a childbearing age who wish to become pregnant during the study period, those who are currently pregnant and/or are breast-feeding, or those who do not wish to use an efficient method of contraception.
?Patients who have taken part in another clinical trial during the past month.
?Patients taking tricyclic antidepressants, imipramine, central antihypertensives (clonidine or reserpine) or beta-blockers.
?Patients who cannot tolerate treatment with Staloral®: hypersensitivity to any of the excipients, serious immune -deficiencies, immune complex diseases, cancer, unstable or badly controlled asthma, autoimmune diseases, diseases that do not tolerate adrenalin usage, serious psychological disorders.
?Patients incapable of reading or understanding the quality of life questionnaires used in this study.
?Patients who refuse to sign the informed consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified