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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00517946 |
Purpose
The purpose of this study is to establish whether MRI scanning is a sensitive measure of the effects of existing drug treatments on nasal dimensions following challenge with intranasal allergen in subjects with hayfever. If successful this technique could be applied to increase confidence for internal decision making and ultimately may be used to assess how effective a new drug treatment is.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: pseudoephedrine hydrochloride Drug: cetirizine hydrochloride |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | An Investigation to Evaluate the Technique of MRI as an Assessment of the Effect of Anti-Allergy Drug Treatment on Internal Nasal and Sinus Mucosal Anatomy Following Intranasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis. |
| Enrollment: | 21 |
| Study Start Date: | March 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00517946 History of Changes |
| Other Study ID Numbers: | RES101509 |
| Study First Received: | August 15, 2007 |
| Last Updated: | May 15, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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MRI, intranasal allergen challenge, seasonal allergic rhinitis (SAR), anti-allergy. |
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Rhinitis, Allergic, Seasonal Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Pseudoephedrine Ephedrine Cetirizine Anti-Allergic Agents Nasal Decongestants |
Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Central Nervous System Stimulants Central Nervous System Agents Sympathomimetics Adrenergic Agents Neurotransmitter Agents |