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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00612820 |
This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis |
Drug: GSK256066 Drug: fluticasone propionate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Efficacy Study |
Official Title: | An 8 Day, Randomised, Double Blind, 3-Way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Fluticasone Propionate in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR) |
Enrollment: | 55 |
Study Start Date: | January 2008 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Pack years = No of cigarettes smoked/day
Exclusion Criteria:
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).
*subjects will require normal serum creatinine clearance values at screening [calculated from serum creatinine by a predicting equation using Cockcroft-Gualt formula]. If the creatinine clearance value is greater than the upper limit of normal as determined by the local laboratory reference range, the Investigator will determine whether this is a clinically significant finding that would preclude participation.
The subject is at risk of non-compliance with the study procedures/restrictions.
The subject is infected with the Hepatitis B, Hepatitis C, or HIV.
Appropriate contraceptive methods for female subjects include:
• Abstinence. The lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication and to continue until the follow up visit.
One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective otherwise it should be used with a barrier method (condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository):
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | IPR110723 |
Study First Received: | January 29, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00612820 |
Health Authority: | Austria: Austrian Medicines and Medical Devices Agency (AGES PharmMed) |
Seasonal Allergic Rhinitis, Vienna Challenge Chamber |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases SARS |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Fluticasone Rhinitis Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Nose Diseases |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents Dermatologic Agents |