A randomised, double-blind, four way cross-over, placebo controlled trial to evaluate the clinical efficacy, onset of action and drug activity at 22-26 hours following the drug intake of Bilastne 20 mg vs placebo and in competition to Cetirizine 10 mg, Fexofenadine 120 mg in reducing symptoms of seasonal allergic rhinitis in grass pollen sensitized volunteers exposed on 2 consecutive days in the Vienna Challenge Chamber

Active, not recruiting

• Conditions: Seasonal Allergic Rhinitis; MedDRA version: 8.1Level: LLTClassification code 10039083Term: Rhinitis

• Registration Number: EUCTR2006-003004-19-AT
• Lead Sponsor: FAES Farma S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 76

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified