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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00612118 |
Purpose
This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, and allergen challenge assessments will also be performed at various time points throughout the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: GSK256066 Drug: azelastine hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, 2-way Crossover Trial of 8 Days Repeat Dosing With Intranasal GSK256066 and Azelastine Hydrochloride in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR) |
| Enrollment: | 70 |
| Study Start Date: | February 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female subject is eligible to participate if she is of:
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.
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00612118 History of Changes |
| Other Study ID Numbers: | IPR110982 |
| Study First Received: | January 29, 2008 |
| Last Updated: | July 22, 2009 |
| Health Authority: | Austria: Medicines and Medical Devices Agency (AGES PharmMed) |
|
Allergic rhinitis, Vienna Challenge Chamber |
|
Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Azelastine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists |
Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Lipoxygenase Inhibitors Enzyme Inhibitors Anti-Allergic Agents Therapeutic Uses Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |