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| Sponsor: | University of Dundee |
|---|---|
| Information provided by: | University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00845598 |
Purpose
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Rhinitis |
Drug: Azelastine , fluticasone Drug: Fluticasone propionate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Proof of Concept Study to Evaluate Comparative Efficacy of an Azelastine/Fluticasone Combination Nasal Spray vs. Twice the Dose of Fluticasone in Persistent Allergic Rhinitis |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Azelastine Fluticasone |
Drug: Azelastine , fluticasone
Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination 1 squirt in each nostril twice daily |
| Active Comparator: Fluticasone propionate |
Drug: Fluticasone propionate
Fluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt)
|
Allergic rhinitis (AR) is a major chronic respiratory disease with a prevalence approaching nearly 25% in the worldwide population.Allergic Rhinitis is a common and relatively undiagnosed public health problem and has been reported as being one of the ten most common causes for outpatient attendances to the general practitioner. Long term untreated allergic rhinitis may lead on to asthma. When exposed to allergens (pollen, house dust mite etc) in the atmosphere, the mast cells in the nose burst and an inflammatory response is triggered and patients experience sneezing, itching, blocked nose and running. These allergens may be used as provocation agents to recreate the disease symptoms to confirm the diagnosis of which allergens one is allergic to. However, there is a risk of allergic reactions in doing so. Adenosine monophosphate (AMP)achieves the same goal by stimulating the mast cells and causing them to burst without actually the risks of allergen provocation tests. Such tests are now commonplace in research and clinical medicine. Nasal steroids are considered to be the most potent medications for allergic rhinitis, particularly nasal blockage. Nasal antihistamines are also available but they act mainly to limit nasal running, itching and sneezing and have lesser effect on blockage. The other advantage is that they act very quickly while steroids take at least 72 hours to begin acting and weeks to achieve maximal benefit. Finally, they are free of significant short and long term side effects. Having said that nasal steroids are very safe and unlike inhaled or oral steroids have not been shown to cause systemic side effects in adults. Therefore, it is interesting to see if a combination of an antihistamine and nasal steroid would add their good qualities mentioned above and by the act of reducing the dose of steroid reduce their side effects. To do this we will use nasal AMP challenge as an outcome measure as we have done research studies for over a decade with. We will look at noninvasive nasal airflow parameters, nasal nitric oxide levels, and for safety we will look at the overnight urinary cortisol and creatinine ratio which is the most sensitive and noninvasive test of urine to quantify how much steroid has been absorbed in the blood stream.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sriram Vaidyanathan, MBBS | +44 1382496355 | s.vaidyanathan@dundee.ac.uk |
| United Kingdom | |
| Ninewells Hospital and Medical School | Not yet recruiting |
| Dundee, United Kingdom, DD1 9SY | |
| Contact: Sriram Vaidyanathan, MBBS +44 1382496355 s.vaidyanathan@dundee.ac.uk | |
| Principal Investigator: Sriram Vaidyanathan, MBBS | |
| Sub-Investigator: Peter Williamson, MRCP | |
| Sub-Investigator: Karine Clearie, MBBCh | |
| Perth Royal Infirmary | Not yet recruiting |
| Perth, United Kingdom, PH1 1NX | |
| Contact: Sriram Vaidyanathan, MBBS +44 1738 473321 s.vaidyanathan@dundee.ac.uk | |
| Principal Investigator: Sriram Vaidyanathan, MBBS | |
| Sub-Investigator: Peter Williamson, MRCP | |
| Sub-Investigator: Karine Clearie, MBBCh | |
| Principal Investigator: | Sriram Vaidyanathan, MBBS | University of Dundee |
| Study Director: | Brian Lipworth, MD, FRCP | University of Dundee |
More Information
| Responsible Party: | Sriram Vaidyanathan, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00845598 History of Changes |
| Other Study ID Numbers: | VAI04 |
| Study First Received: | February 17, 2009 |
| Last Updated: | January 11, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Allergic Rhinitis |
|
Rhinitis Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Azelastine Fluticasone 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 Dermatologic Agents Anti-Inflammatory Agents |