E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Perennial allergic rhinitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034382 |
E.1.2 | Term | Perennial allergic rhinitis |
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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 show that levocetirizine is more effective than placebo in the treatment of nasal obstruction due to perennial allergic rhinitis |
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E.2.2 | Secondary objectives of the trial |
To investigate patients' appreciation of the clinical relevance of the effect of levocetirizine on their symptoms of perennial allergic rhinitis To investigate the effect of levocetirizine on symptoms of perennial allergic rhinitis different from nasal obstruction.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- At least 2 year history of perennial allergic rhinitis with pronounced symptoms. - Sensitization to D. farinae or D. pteronyssinus proved by a prick test (wheal diameter ≥ 3 mm) or measurement of specific IgE (at least RAST class 2) at most one year ago. - On visit 2: Sum of the morning nasal obstruction scores documented in the screening diary is at least 40% of the maximal sum the patient could have attained.
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E.4 | Principal exclusion criteria |
- Severe diseases and diseases, conditions or findings which might interfere with the study results, deteriorate due to study participation or require impermissible medication. In particular this includes (a) restricted liver or kidney function, (b) nasal polyps, severe deviations of the nasal septum, and any other considerable impairments of nasal patency, (c) an ear, nose or throat inflammation during the last 2 weeks or any other but allergic form of rhinitis, (d) asthma requiring any other treatment than short acting β-agonists on demand, (e) atopic dermatitis with considerable probability to require corticosteroid treatment. - Intake of impermissible medication or non observance of the designated washout periods.
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E.5 End points |
E.5.1 | Primary end point(s) |
Average morning nasal obstruction score calculated from diary assessments during treatment. |
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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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Yes |
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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In case there is evidence, that the study will not provide meaningful results, or that continua-tion implies injustifiable risks to the patients, the study is terminated immediately. Further-more the study may be concluded for administrative reasons. |
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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 | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |