Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergic rhinoconjunctivitis to pollen of Ambrosia - Sublingual immunotherapy with Lais Ambrosia Tablets

OFARMA0 sitesMarch 2, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 2, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OFARMA

•\-Signed Informed Consent \-Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. \-clinically relevant sensitization to ragweed pollen \-Positive clinical history to ragweed pollen \-Availability to attend the study visits requested by the protocol during the study participation \-Negative Pregnancy Urinary test (if female in fertile age) \-If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. \-Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. \-Positive response to the TPN test.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 100
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 5

•\- Concomitant participation in other interventional clinical trials \- Previous immunotherapy with ragweed allergen in the last 3 years. \- Ongoing immunotherapy. \- clinically relevant sensitization to other stagional aereous allergens such as Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, and/or to perennial allergens like house dust mites, cats and dogs dander. \- Patients being in any relationship or dependence with the sponsor and/or investigator \- Other reasons contra\-indicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions) \- Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection \- Predominant perennial allergic rhinitis \- Partly controlled or uncontrolled asthma \- Chronic asthma or emphysema, particularly with a FEV \<70% of the predicted value \- Galactose\-intolerance or malabsorption syndrome \- Active tuberculosis \- Generally inflammatory as well severe acute and chronic inflammatory diseases \- Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis) \- Immune deficiency (for example induced by immunosuppressive drugs) \- Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism \- Malignancy \- Alcohol abuse.