Respiratory Allergy: Asthma and allergic rhinitis due to grass pollen
Conditions
Interventions
Trade Name: Staloral Pollens maintenance 300 IR/ml sublingual solution
Pharmaceutical Form: Sublingual spray, solution
Pharmaceutical form of the placebo: Sublingual spray, solution
Route of administr
Sponsors
Dr. Javier Domínguez Ortega
Eligibility
Sex/Gender
All
Inclusion 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. ? 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess asthma control by means of the score difference according to the Composite Asthma Severity Index (CASI)10, which measures and assesses in a multidimensional form the nature of the asthma. This difference will be assessed with respect to the baseline value and between the two treatment groups (Staloral® vs placebo), in patients with grass-pollen allergic rhinitis, after two seasons of treatment;Secondary Objective: Clinical assessment of asthma and rhino-conjunctivitis in the two treatment groups after the first and second seasons of treatment. Assess the percentage of patients who improve in asthma control (those who pass from partially controlled to well controlled or pass from badly controlled to partially controlled) and who, moreover, maintain or improve in the therapeutic stage of asthma treatment (1-6). Assessment of quality of life and satisfaction with regard to treatment. Evaluate changes in serum markers (baseline and final): IgE and IgG4 against Php p 1, Php p 5, Php p 7 +12 and explore the response to immunotherapy through variation dependent innate immune markers of dendritic cells as Programmed Cell Death Ligand 1 (PD-L1) or Stabilin 1 (STAB1). Assess the safety profile of treatment with Staloral®. Rating of pollination within the study period and correlation with symptoms and disease control in both groups.;Primary end point(s): Composite Asthma Severity Index (CASI);Timepoint(s) of evaluation of this end point: AT THE END OF THE STUDY | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical assessment of asthma. Clinical assessment of the rhinoconjunctivitis. Evaluate changes in serum markers (baseline and final) Evaluate the safety profile of the STALORAL® treatment. Pollination in the period of the study and correlation with the symptoms and control of the disease in both groups;Timepoint(s) of evaluation of this end point: AT THE END OF THE STUDY | — |
Countries
Spain
Contacts
Public ContactCARMEN SANTOS COCA
3D HEALTH RESEARCH SL
Outcome results
None listed