E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal Allergic Rhinitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal 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 study the effects of Seasonal Allergic Rhinitis on Cognitive functions and actual driving and the modifying effect of treatment with systemic or topical medication |
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E.2.2 | Secondary objectives of the trial |
To study the effects of Seasonal Allergic Rhinitis on Mood |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. All patients must be normal healthy males or females, age between 21 and 45 years, diagnosed with seasonal AR (SAR), also known as Intermittent Rhinitis (ITR); Anti-allergic treatment during the previous season, positive radioallergosorbent test for serum-specific immunoglobulin E or positive skin prick test for tree/ and/or grass- and/or weed pollen. The severity of nasal symptoms (itching, secretion, sneezing and congestion) is rated by the Allergy Symptom Check List (ASCL, Kremer et al 2002); before a nasal challenge is performed patients should score less than four. 2. Patients must be experienced drivers. That is, each shall have held a driver’s license for at least the preceding two years and shall have driven more than 5,000 km/yr (3,000 miles/yr) during that period. 3. Patients must be in general good health as confirmed by routine clinical and laboratory testing. Clinical laboratory tests ( CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the Investigator/`medical supervisor. 4. Patients must have a negative urine screen at Screening for drugs with a high potential for abuse. 5. Patients must be free of any clinically significant disease, which would interfere with the study evaluations. 6. Patients must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements. 7. Patients must be able to communicate, participate, and comply with the requirements of the entire study, including completion of all visits. 8. In females of childbearing potential, the serum pregnancy test (HCG) must be negative at the Screening Visit. 9. Weight: within 10% of normal average for the individual’s sex, age and height. 10. Vision: normal binocular acuity, corrected, or uncorrected.
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E.4 | Principal exclusion criteria |
1. Patients who have clinically significant abnormal physical findings or vital signs at the Screening physical examination (as determined by the Investigator) which could interfere with the objectives of the study. This includes patients who have any history or symptoms of chronic illness, history of psychotic disorders, drug addiction or abuse of drugs or alcohol, or impaired mentation which could interfere with the completion of the study. 2. Patients requiring any CNS medication during the study, or medication with sedative effects which could interfere with the objectives of the study. 3. Patients who have taken participated in an investigational drug trial within one month prior to the Screening Visit. 4. Patients with a history of allergies to more than two classes of medication or who are allergic to or cannot tolerate antihistamines. 5. Excessive smoking; i.e., more than ten cigarettes per day or the equivalent. 6. Excessive consumption of beverages containing caffeine; i.e., more than five cups per day. 7. Patients with active seasonal and/ or perennial allergic rhinitis. 8. Pregnant or nursing females. 9. The investigational study staff who is involved with this study. 10. Patients previously randomized into the study. 11. Patients who have taken a sedative/hypnotic, antihistaminic or anticholinergic drug during the two weeks prior to entering the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are the performance on a standard driving test and the performance on a verbal memory test. Related outcome variables are:
· Standard Highway Test Primary outcome variable: Standard Deviation of Lateral Position (SDLP): cm. Secondary outcome variable: Standard Deviation of Speed (SDSP): km.
. WLT- 15 Memory test Primary outcome variable: Total words recalled (Immediate recall) Secondary outcome variable: Total words recalled after 30 minutes (delayed recall)
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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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End of trial is defined as last patient last visit |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |