E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal Allergic Rhinitis |
|
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 | 10039083 |
E.1.2 | Term | Rhinitis |
|
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 |
Investigate effect of single dose of Bilastine 20mg vs. placebo on TNSS (total nasal symptom score) of allergic rhinitis provoked by spending 4h in the VCC after dosing on day 1. |
|
E.2.2 | Secondary objectives of the trial |
Investigate effect of single dose of Bilastine 20mg vs. Cetirizine 10mg and Fexofenadine 120mg on TNSS (total nasal symptom score) of allergic rhinitis provoked by spending 4h in the VCC after dosing on day 1.
Explore effects of single dose of Bilastine 20mg compared to Cetrizine 10mg, Fexofenadine 120mg and placebo on nasal, eye and other symptoms, nasal obstruction (anterior rhinomanometry) and secretions in allergic rhinitis provoked by spending 4h in the VCC post-dose on day 1.
Explore effects of single dose of Bilastine 20mg compared to Cetrizine 10mg, Fexofenadine 120mg and placebo on nasal, eye and other symptoms, nasal obstruction (anterior rhinomanometry) and secretions in allergic rhinitis provoked by spending 4h in the VCC on day 2 (22 – 26h post-dose day 1), as a measure of persistent drug activity.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests. - They are aged 18 to 55 years inclusive. - They have a history of seasonal allergic rhinitis (SAR). - They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom score of at least 6. (Nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which have been scored on a scale from 0 to 3). - They will not have reduced symptoms (>2 symptom scoring points from the qualification score) after a single dose of placebo at the last scoring in the following hour of the qualifying session. - They have a positive skin prick test (wheal 3mm) for grass pollen at or within the 12 months preceding the screening visit. - They have a positive RAST ( class 2) for grass pollen at or within the 12 months preceding the screening visit. - There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours. - They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form. - They are available to complete all study measurements.
|
|
E.4 | Principal exclusion criteria |
- Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). - On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study. - Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function. - The subject has a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation. - The subject has participated in any clinical study in the previous month. - The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. - Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis). - The subject is at risk of non-compliance with the study procedures/restrictions.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Weighted mean total nasal symptom score (TNSS) (nasal obstruction, rhinorrhoea, itchy nose and sneezing) 0-4h post-dose period spent in the VCC on day 1. |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Onset of action, duration of action |
|
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) | 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 | 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.8.5 | 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
| |
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 | |