Prospective, open uncontrolled study to evaluate the safety of Depigoid with two pollen combinations ( Grasses/Olea and Grasses/ Parietaria) 2000 DPP/ml in patients with allergic rhinitis or rhinoconjunctivitis with or without seasonal asthma.

aboratorios LETI, S.L.0 sitesAugust 23, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Allergic rhinitis or rhinojunctivitis, with or without seasonal asthma to more than one of the following pollens: Grasses, Olea europaea and Parietaria judaica.
Sponsor: aboratorios LETI, S.L.
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

August 23, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

aboratorios LETI, S.L.

•\-Subject has dated and signed the informed consent.
•\-Men and women between 18 and 60 years of age (both inclusive).
•\-Individuals suffering symptoms of allergic rhinoconjunctivitis or rhinitis during at least the preceding year, with or without allergic seasonal asthma caused by a clinically relevant sensitization to pollens (grasses AND P. judaica or O. europaea). Asthmatic patients can be included in the trial only if seasonal asthma is controlled with a medium daily dose minor or equal to 800 µg/day of budesonide or an equivalent or minor or equal to 400 µg/day of budesonide or an equivalent plus a long\-acting\-?2 agonist.
•\- Asthmatic patients must be stable within 3 months prior to Visit 1 and on an stable inhaled steroid dose within 6 weeks prior to visit 1 and throughout the study. FEV1 must be ? 80% of predicted value.
•\-The IgE\-mediated sensitization must be demonstrated by the following: medical history AND IgE specific CAP RAST ? 2 to the suspected relevant pollens (grass pollen AND Olea and/or Parietaria) AND a positive skin prick test to grass and Olea and/or Parietaria.
•A skin prick test will be considered positive when it produces a wheal of at least 3 mm according to the largest diameter.
•Are the trial subjects under 18? no
•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 54

•\-Any contraindication for treatment with allergen specific immunotherapy.
•\-Forced expiratory volume in 1 s (FEV1\) or peak expiratory flow (PEF) value \<80% of the predicted normal value.
•\-Clinically relevant allergy symptoms due to sensitization to perennial allergens (mites, molds, epithelia) or other seasonal pollen which might interfere with the safety of the IMP.
•\-Asthma requiring a dose \> 800 µg/day of Budesonide or an equilent, without long\-lasting beta\-2 agonists or requiring a dose \> of 400 µg/day of Budesonide or an equivalent plus a long\-acting\-?2 agonist to reach asthma control, according to the Global Initiative for Asthma (GINA 2010\)
•\-Patients with non controlled bronchial asthma within 3 months prior to Visit 1\.
•\-Patients with asthma who have been treated with systemic steroids within 3 months prior to V1\.
•\-Patients with hospital admission due to asthma exacerbations within 1 year prior to V1\.
•\-Acute or chronic inflammatory or infectious diseases of the airways.
•\-Chronic structural diseases of the respiratory system (for example, emphysema or bronchiectasis).
•\-Immune system diseases, both autoimmune diseases and immunodeficiency.