| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Adult subjects suffering from seasonal allergic rhinitis (SAR) due to grass pollen |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10039776 |
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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 compare clinical efficacy of levocetirizine 5 mg and desloratadine 5 mg as measured by the subjects’ satisfaction/dissatisfaction (percentage of switches: i.e., subject’s choice after one week of treatment to continue with the administered treatment or to switch to the alternative treatment) after the first week of treatment.
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| E.2.2 | Secondary objectives of the trial |
•To investigate the correlation between the switch
•and the mean T5SS over the first week of treatment.
•and the mean change from the baseline in T5SS over the first week of treatment.
•and the mean of 5 individual symptom scores over the first week of treatment.
•and the mean change from the baseline in the 5 individual symptom scores over the first week of treatment.
•To compare levocetirizine 5 mg and desloratadine 5 mg after the first week of treatment in the switched population analyzing the reason for dissatisfaction.
•To assess, at the end of the study, subjects’ satisfaction/dissatisfaction of their choice of treatment after the first week of treatment.
•To investigate subject’s evaluation of disease evolution as assessed on the standard 7 point Global Evaluation Scale after the first week of treatment.
•To evaluate the safety profile of levocetirizine. |
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
The subjects should meet the following criteria at V1 (or at pre-screening visit (V0) when applicable):
•Have been informed of the nature and aims of the study (refer to ICF) and have given their written informed consent signed and dated (at V1 or at pre-screening visit (V0)).
•At least 2-year history of SAR that became symptomatic during annual from grass pollen season and requiring treatment (also at least since 2 years) during annual from grass pollen.
•Adult subjects older than 18 years of either sex.
•Out-patients.
•Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥ 3.5 IU/ml) to grass pollen (less than 1 year).
•Female subjects of childbearing potential must agree not to become pregnant during the study. Female subjects are considered of non-childbearing potential before menarche, or at least two years after menopause, or if they had a total hysterectomy or a bilateral ovariectomy or a congenital sterility. When sexually active, females of childbearing potential must be using a medically accepted contraceptive method (hormonal birth control, per os, injectable or by implant, for at least 2 months), have had a bilateral tubal ligation, have monogamous relationship with vasectomized partner or agree to use intrauterine device, diaphragm with spermicide or male condom with spermicide. The female subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive medthod, and undertake to inform the Investigator of any potential change in status. Female subjects with childbearing potential are eligible if they have a negative urine pregancy test at V1.
•Subjects considered as reliable and mentally capable of adhering to the protocol (i.e., completing the daily record card), according to the judgement of the Investigator (at V1 or at pre-screening visit (V0)).
The subjects should meet the following criteria at V2:
•Minimum mean T5SS of 8 during the baseline 3 to 7 days period.
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| E.4 | Principal exclusion criteria |
To enter the study at Visit 1, the subjects should not:
•Be pregnant (positive urinary pregnancy test) or lactating.
•Have an ear, nose and throat (ENT) or eye infection during the two weeks preceding visit 1 (e.g., sinusitis, purulent rhinorrhea, common cold, ...)
•Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
•Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
•Have an associated ENT disease such as vasomotor rhinitis, significant chronic sinusitis, obstructive nasal polyposis, obstructive deviation of the nasal septum, rhinitis medicamentosa
•Have another clinically significant disease (e.g. cardiovascular, hepatic, renal, auto-immune or associated with haematology, neurology, psychiatry) or any other disease which would disturb absorption, distribution, metabolism or excretion of the investigational products.
•Be incapable of giving their written informed consent
•Be initiating or changing the dose of an immunotherapy regimen during the course of the study or during the month preceding visit 1.
•Intake of medications prohibited before the screening visit V1, with the following wash-out periods:
•intranasal or systemic corticosteroids (30 days)
•ketotifen (14 days)
•nedocromil or cromoglycate (14 days)
•topical corticosteroids (14 days)
•loratadine, desloratadine (10 days)
•leukotriene antagonist or synthesis inhibitors (7 days)
•H1 antihistamines (3 days)
•decongestants (per os, nasal sprays or drops) (3 days)
•Be hypersensive to levocetirizine or its excipients, desloratadine or to any other piperazine derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine.
•Be expected non compliant with the investigational products or with the protocol requirements
•Have a known lack of response to H1- antihistamines,
•Have an history of alcoholism, drug addiction, mental instability,
•Have participated in a clinical trial during the last three months before V1,
•Have already been selected in this trial
•Subjects intending to donate blood during the trial
•The investigator, co-investigators, as well their children or spouses and all the study collaborators should not be enrolled in this study.
To continue the study at Visit 2, the subjects should not:
•Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days
•Have a mean T5SS < 8 over the selection period
•Have taken any prohibited medication during the selection period
•Have presented during the selection period with any of the exclusion criteria checked at Visit 1
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Criteria for evaluation :
Efficacy variables:
Primary variable:
Percentage of subjects who decided to switch to alternative treatment.
Secondary variables:
•T5SS over Week 1 – mean absolute score and mean change in score from baseline.
•Individual symptom scores over Week 1 – mean absolute score and mean change in score from baseline.
•Global Evaluation Scale score at the end of Week 1.
•Reasons for switching to alternative treatment at the end of Week 1
•Number of subjects, at the end of Week 3, satisfied by their choice to switch to alternative treatment
Exploratory variables:
•T4SS over Week 1 - mean absolute score and mean change in score from baseline.
•T4SS over Week 3 - mean change in score from Week 1
•Individual symptom score over Week 3 - mean change in score from Week 1
•Time to first feeling of symptom improvement during Week 1
•Time to first feeling of sufficient symptom improvement during Week 1
•VAS score rating the speed of overall symptom relief at end of Week 1
•VAS score rating the severity of blocked nose at randomization and at the end of Week 1 – mean absolute score and mean change in score from randomization to the end of Week 1
•VAS score rating the speed of blocked nose relief at end of Week 1
•VAS score rating the impact on quality of sleep and daily activities at end of Week 1
Safety variables :
Frequency, severity, nature and duration of adverse events reported by the subjects during the whole duration of the study, physical examination and vital signs.
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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 | 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 | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| 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) | Yes |
| 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
| 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 | 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 end of trial is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subjects data have ended.
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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 | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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