E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Intermittent Allergic Rhinitis (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 | PT |
E.1.2 | Classification code | 10039085 |
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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 |
The primary objective is to compare the efficacy and safety of DL with placebo in the symptomatic treatment of subjects 12 years and older with intermittent allergic rhinitis (IAR). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to compare the effects of DL to those of placebo on quality of life and impact on productivity and health care utilization. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject must meet ALL the criteria listed below for entry:
1. For this study, the diagnosis of IAR is not based solely on the current episode of AR. Subjects must have at least a 2 year history of AR consistent with IAR (defined as symptoms of allergic rhinitis present less than four days per week or for less than four consecutive weeks per year); the current episode can count as the second year. 2. Subjects must be 12 years of age and older, of either sex and of any race. 3. At the Run-in Visit, subjects must be sufficiently symptomatic, with a T5SS 12 hour AM-PRIOR (reflective) symptoms severity score of at least 6. 4. In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR (reflective) T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be >=30. 5. Subjects must have a positive skin-prick test at screening to one or more allergens in the GA2LEN (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active. 6. Subjects must be free of any clinically significant disease, other than IAR, which would interfere with the study evaluations. 7. Subjects, or parents or legal guardians, must give written informed consent. Subjects must be able to adhere to dose, visit schedules and meet study requirements. 8. In females of childbearing potential, the urine pregnancy test (hCG) must be negative at the Screening Visit. 9. Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed IUD, or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy, and tubal ligation), or be at least 1 year postmenopausal.
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E.4 | Principal exclusion criteria |
The subject will be excluded from entry if ANY of the criteria listed below are met:
1. Subjects with a history of anaphylaxis and/or severe local reactions(s) to skin testing with allergens. 2. Subjects with intolerable symptoms that would make participating in the study unbearable. 3. Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening. 4. Subjects with asthma who require chronic use of inhaled or systemic corticosteroids. 5. Subjects with a current of history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. 6. Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study. 7. Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids. 8. Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1. 9. Female subjects who are pregnant or nursing. 10. Subjects with a history of hypersensitivity to the study drug or to their excipients or known to not tolerate any antihistamine. 11. Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff’s family. 12. Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that preclude the subject’s participation in the study. 13. Subjects whose ability to provide informed consent is compromised. 14. Subjects with a history of noncompliance with medications or treatment protocols. 15. Subjects with rhinitis medicamentosa. 16. Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow. 17. Subjects who have not observed the medication washout times outlined in the protocol prior to Visit 2.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for the study is the change from baseline in the 12-hour AM/PM-PRIOR (reflective) total 5 symptom score (T5SS) from subject daily diaries averaged over treatment Days 1 to 15. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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The end of trial will be when the last subject has had their last visit or communication with investigator. |
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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 | 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 |