Evaluating the efficacy, safety, tolerability of use and treatment adherence in two different dosing schedules, pre-costagionale and costagionale, of a sublingual allergoid (Lais Parietaria)administered to patients suffered from oculorhinitis with or without bronchial asthma by Parietaria. Randomized double-blind, multicenter, parallel group, placebo-controlled. - ParLais/09

• Conditions: Subjects with Parietaria pollen allergy.; MedDRA version: 9.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitis

• Registration Number: EUCTR2008-007657-12-IT
• Lead Sponsor: OFARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged between 18 and 60 years, male and female. 2. Clinical history of rhinitis (oculorhinitis) intermittent mild to persistent moderate/severe asthma with or without intermittent allergic grade by at least 2 years. 3. Presence of symptoms only during the pollen season Parietaria. 4. Awareness Parietaria confirmed by skin test (skin prick) positive for Parietaria with hives with an average diameter of 3 mm higher than the negative control hives. 5. Subjects with sufficient degree of cooperation and understanding that have agreed to study and provided informed consent signed for confirmation.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Sensitisation to other allergens with possible overlap of pollen such as: Grasses, Cypress, Birch
2. Bronchial asthma or severe persistent with FEV1 <80% of theoretical value
3. Sensitisation to cat or dog if the animal is present in your home
4. Systemic immunological diseases congenital or acquired immunodeficiencies
5. Diabetes, severe heart disease, neoplastic diseases actually or previous
6. Diseases that require chronic treatment with corticosteroids, immunosuppressants or beta -
blocker
7. Neurological-psychiatric diseases (requiring psychotropic drugs more)
8. Ongoing pregnancy or lactation
9. Parietaria specific immunotherapy for the last 5 years

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy in two different dosing schedules, pre-costagionale and costagionale, of Lais Parietaria sublingual, versus placebo.;Secondary Objective: -Reduction of symptoms and consumption of symptomatic drugs, assessed separately -Days without symptoms, days without use of symptomatic medications -Number of extra visits -Safety (adverse events) -Evaluation of effectiveness (by the subject and the Investigator) -Adherence to the treatment of the subject (compliance) -Guest on the quality of life of the subject;Primary end point(s): To compare the efficacy in two different dosing schedules, pre-costagionale and costagionale, of Lais Parietaria sublingual, versus placebo.