Asthma and allergic rhinitis
Conditions
Interventions
Trade Name: Alternaria alternata major allergen
Product Name: Alternaria alternata major allergen
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: Alternaria alternata major allergen
Con
Sponsors
DIATER LABORATORIES S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female patients, with age range 12-75 years, no smoking (6 months). -Diagnosis of asthma (American Thoracic Society criteria) or allergic rhinitis (conventional criteria), without severe exacerbations (during 3 months). -Treated during 12 previous weeths con short action beta2 -agonists or with a beclometasone dose equal or minor than 1000 microg/day or with budesonide dose equal or minor than 800 microg/day or with a fluticasone dose equal or minor than 500 microg/day. -Alternaria sensitized (with positive prick test) with or without others perenne allergens, but unsensitized to Parietaria or Chenopodiaceas (Chenopodium, Salsola) allergens. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients with evidence of severe disease (organic or psiquiatric), pregnancy,having participating in another clinical trial during 4 previous weeths, previous inmunotherapy, intake of corticosteroids during 3 previous months, inmunotherapy with others allergens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -To evaluate the effect of inmunotherapy with Alternaria alternata 1 on: -others markers as inflammation markers and oxidative stress markers (pH, hydrogen peroxide) -bronchial responsiveness to methacholine -respiratory functional parameters (VEMS,FVC, FEV1/FVC, FEF25-75) -seric cytocines ;Primary end point(s): -Efficacy determinants: AMP concentration that induces a FEV1 deterioration of 20% (PC20) and exhaled nitric oxide concentrations. -Safety: clinical evaluations and monitoring of adverse effects. ;Main Objective: -To evaluate the effects of inmunotherapy with Alternaria alternata 1 on AMP bronchial answer and his increments, in asthmatic patients and in patients with allergenic rhinitis sensitized to this allergen. -To identificated the effects of inmunotherapy with Alternaria alternata 1 on exhaled nitric oxide concentrations and on increments of this inflammation marker due to the allergen natural exposition, in asthmatic patients and in patients with allergenic rhinitis sensitized to this micotic allergen. | — |
Countries
Spain
Outcome results
None listed