E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perennial allergic rhinitis is a autoinmuno disease and its pathopshysiology is based on released of several mediators, such as histamine. The symptoms include: itchy eyes and palate, runny nose, sneezing and nasal obstruction. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6 |
E.1.2 | Level | pt |
E.1.2 | Classification code | 10039094 |
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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 assess long term safety of rupatadine 10 mg fumarate in the treatment of moderate-severe persistent allergic rhinitis in 12 months follow-up. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Men or women over the age of 12 2. Patients with a history of moderate-severe persistent allergic rhinitis for at least 12 months before the date of inclusion in the study (patients sensitized to pollens and moulds should be allowed to participate as long as they are not in a clinically relevant symptom phase). 3. Patients must undergo cutaneous prick test (+) for some allergen responsible for rhinitis. The test must be done the first day of inclusion unless the patient already has a prior prick test (+) for such allergens done in the 12 months prior to the date of inclusion. For the purposes of including a patient in the study, the prick test for a given allergen should be considered positive if the diameter of the papule obtained is at least 3 mm larger than the negative control. 4. Corrected Q-T interval values below 430 msec. in men and 450 msec. in women and an ECG with no clinically important abnormalities. No abnormality of cardiac rhythm, bradycardia below 55 beats/minute or history of cardiovascular disease.
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E.4 | Principal exclusion criteria |
1. Patients with non-allergic rhinitis (vasomotor, infectious, drug-induced, etc.). 2. Patients with allergic rhinitis sensitized to pollens and to moulds in acute symptom phase. 3. Negative cutaneous prick test 4. Patients with obstructive nasal polyps or a significant deviation of the nasal septum, at the investigator criterion. 5. Known hypersensitivity to piperazines (e.g. cetirizine, hydroxyzine) or piperidines (e.g. loratadine), other compounds structurally similar to study drug or any of the components of the study medicinal products. 6.Abnormal hematologic (total and differential blood cell counts) and biochemical values: serum glucose, electrolytes (sodium, potassium and chlorine), SGOT, SGPT, -GT, total bilirubin, alkaline phosphatase, total proteins, urea, creatinine, total cholesterol, triglycerides, CPK according to the normal reference values that, according to the investigator, are clinically significant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentatge of Serious Adverse Events |
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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 | No |
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 | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
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.8.5 | 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 | Information not present in EudraCT |
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
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The only justification of early study finalitzation would be a related Serious Adverse Events which may compromise the patient health. Otherwise, the study will finalise after 12 months follow.up. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |