E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with Parietaria pollen allergy. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy in two different dosing schedules, pre-costagionale and costagionale, of Lais Parietaria sublingual, versus placebo. |
|
E.2.2 | Secondary objectives of the trial |
-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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To compare the efficacy in two different dosing schedules, pre-costagionale and costagionale, of Lais Parietaria sublingual, versus placebo. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |