| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 | 10001723 |
|
| 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 mean change from the baseline of Total 4 Symptom Score (T4SS)
over two weeks of treatment. T4SS: sum of the individual symptom scores for
sneezing, rhinorrhea, nasal pruritus, ocular pruritus, evaluated on a 4-point scale
retrospectively over the past 24 hours. |
|
| E.2.2 | Secondary objectives of the trial |
• To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg as
measured by the mean change from the baseline of T4SS over the first week of
treatment.
•To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg as
measured by the mean change from the baseline of the 5 individual symptom scores
for sneezing, rhinorrhea, nasal pruritus, ocular pruritus and nasal congestion
evaluated on a 4-point scale retrospectively over the past 24 hours, over the first
week and over two weeks of treatment.
•To compare clinical efficacy of Levocetirizine 5 mg and Desloratadine 5 mg vs.
placebo as measured by the mean change from the baseline of T4SS and the 5
individual symptom scores for sneezing, rhinorrhea, nasal pruritus, ocular pruritus
and nasal congestion evaluated on a 4-point scale retrospectively over the past 24
hours, over the first week and over two weeks of treatment.
|
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
To enter the study, subjects should meet the following criteria:
At Visit 1
• Be informed of the nature and aims of the study (refer to ICF) and be their written
informed consent to participate in this study
•Male or female out subject aged ≥18 years
•Female subjects of childbearing potential must agree not to become pregnant during thestudy. 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 bilateralovariectomy or a congenital sterility. When sexually active, females of childbearingpotential must be using either oral contraceptives, contraceptive trans-dermal device,contraceptive injections for at least two months; have had a bilateral tubal ligation; havemonogamous relationship with vasectomized partner or agree to use intra-uterinedevice, diaphragm with spermicide, or male condom with spermicide.
•Be able to understand the information given and the text of the informed consent, tocomplete the daily record card (See Appendix 18.1), as well as to discuss with the
Investigator.
•At least 2-year history of seasonal allergic rhinitis that became symptomatic during theannual grass pollen season.
•A skin test or a RAST (Radio Allergo Sorbent Test) for grass pollens :
• a skin prick test is positive when the wheal is > 3mm larger than the diluent
control,
•a RAST is positive if > class 3 or > 3.5 IU/mL.
These tests must have been performed during the preceding year. If none is available, a
skin test should be performed at Visit 1.
At Visit 2
• Have rhinitis symptoms of such severity that the mean T4SS (Total 4 Symptom Score:
Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus) over the baseline period must be≥6. The mean T4SS is calculated taking into account only the days on which the
scores of these four symptoms are available. For this reason, the selection period can be reduced up to three days or increased up to seven days if necessary.
The rhinitis symptoms (Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and
Nasal Congestion) must be evaluated and recorded on the diary card by the subjects
using the following scale:
0 = Absent
1 = Mild (present but not disturbing)
2 = Moderate (disturbing but not hampering daytime activities and/or sleep)
3 = Severe (hampering daytime activities and / or sleep)
|
|
| E.4 | Principal exclusion criteria |
To enter study at Visit 1, subjects should not:
• Be pregnant (positive urinary pregnancy test) or lactating,
•Have an ear, nose, throat (ENT) infection during the two weeks preceding Visit 1 (e.g.sinusitis, purulent rhinorrhea, common cold…),
•Have an associated asthma requiring corticosteroid treatment,
•Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or 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, rhinitismedicamentosa,
•Have another clinically significant disease (cardiovascular, hepatic, renal, auto-immuneor associated with hematology, neurology, psychiatry), or any other disease whichwould disturb absorption, distribution, metabolism or excretion of the investigationalproducts,
•Be initiating or changing the dose of an immunotherapy regimen during the course ofthe study or during the preceding month
•Have to use during the course of the study any of the following medications or have
used them within the specified wash-out periods :
intranasal or systemic corticosteroids 30 days
ketotifen 14 days
nedocromil, cromoglicate 14 days
other topical corticosteroids 14 days
loratadine, desloratadine 10 days
leukotriene antagonists or synthesis inhibitors 7 days
other antihistamines 3 days
decongestants (per os, nasal spray or drops) 3 days
•Be hypersensitive to levocetirizine or its excipients, or to any other piperazine
derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine, buclizine,
•Be hypersensitive to desloratadine or its excipients.
•Known lack of response to H1-antihistamine treatment,
•Be incapable of giving their written informed consent,
•Be expected to be non compliant with the study treatments or with the requirements of the protocol,
•Have a history of alcoholism, drug addiction, mental instability,
•Have participated in a clinical trial during the last three months,
•Have already been selected in this study,
•Be intending to donate blood during the study,
•Be neither an investigator, a co-investigator, their children or spouses, nor anyone of the study co-workers
To continue the study at Visit 2, subjects should not:
• Have a selection period (Visit 1-Visit 2) inferior to three days or superior to seven days
•Have a mean T4SS < 6 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 Visit1
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Criteria for evaluation :
Efficacy variables :
Primary:
Change from the baseline of T4SS (T4SS: sum of the individual symptom scores for
sneezing, rhinorrhea, nasal pruritus, ocular pruritus, evaluated on a 4-point scale
retrospectively over the past 24 hours) over two weeks of treatment with
Levocetirizine 5 mg, Desloratadine 5 mg or 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 | 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 | Yes |
| 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 | 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.8.5 | The trial involves multiple Member States | Yes |
| 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
|
| 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. |
|
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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