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Sponsored by: |
University of Dundee |
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Information provided by: | University of Dundee |
ClinicalTrials.gov Identifier: | NCT00487032 |
We wish to evaluate the onset of tolerance to nasal decongestants like oxymetazoline (available over the counter) and the mechanism of tolerance particularly with differential effects on alpha 1 and alpha 2 adrenoreceptors on the nose. This we will 'tease' out by using an alpha 1 blocker called Prazosin. We hypothesize that alpha 1 receptors mediate arterial constriction and this will be captured by measuring nasal blood flow. We also hypothesize that alpha 2 receptors mediate venous sinusoid constriction and this we will capture by airflow parameters like Peak Nasal Inspiratory Flow, Rhinomanometry, Oscillometric indices etc.
Condition | Intervention | Phase |
---|---|---|
Allergic Rhinitis Tachyphylaxis Rhinitis Medicamentosa |
Drug: Oxymetazoline 0.05% w/v Drug: Budesonide aqueous nasal spray 64 micrograms Drug: Prazosin 1 mg tablet Drug: Placebo tablet to Prazosin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Proof of Concept Study to Evaluate Differential Tachyphylaxis of Alpha 1 and Alpha 2 Adrenoreceptor Mediated Decongestant Response to Oxymetazoline and Its Acute Reversal by Corticosteroid in Healthy Volunteers |
Estimated Enrollment: | 31 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | February 2009 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sriram Vaidyanathan, MRCS, DOHNS | +44 7791735797 | s.vaidyanathan@dundee.ac.uk |
United Kingdom, Perthshire | |
Perth Royal Infirmary (Tayside NHS Trust) | |
Perth, Perthshire, United Kingdom, PH1 1NX | |
United Kingdom, Tayside | |
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee) | |
Dundee, Tayside, United Kingdom, DD1 9SY |
Principal Investigator: | Sriram Vaidyanathan, MRCS, DOHNS | University of Dundee |
Study Director: | Brian Lipworth, MD, FRCP | University of Dundee |
Study ID Numbers: | VAI03, 2007−003194−82 |
Study First Received: | June 14, 2007 |
Last Updated: | June 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00487032 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
allergic rhinitis rhinitis medicamentosa imidazolines corticosteroid |
Pseudoephedrine Otorhinolaryngologic Diseases Budesonide Rhinitis Healthy Naphazoline Oxymetazoline |
Respiratory Tract Diseases Respiratory Tract Infections Prazosin Phenylephrine Guaifenesin Ephedrine Phenylpropanolamine |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Physiological Effects of Drugs Adrenergic Agonists Nasal Decongestants Therapeutic Uses Vasoconstrictor Agents Appetite Depressants Adrenergic alpha-Agonists Sympathomimetics |
Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Protective Agents Pharmacologic Actions Nose Diseases Anti-Obesity Agents Mydriatics Autonomic Agents Expectorants Adrenergic Antagonists Peripheral Nervous System Agents Central Nervous System Agents |