Azelastine Fluticasone Combination vs. Fluticasone
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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 4 |
| 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 |
- Maximum percentage fall in PNIF after 400mg/ml of AMP nasal challenge between both groups. [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: No ]
- 60 minute recovery to AMP challenge [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Mini RQLQ [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Global visual analogue scale [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Nasal lavage for cytokines [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: No ]
- Overnight urinary cortisol creatinine ratio [ Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks ] [ Designated as safety issue: Yes ]
- Domiciliary diary cards [ Time Frame: 2 week treatment periods ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| 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)
|
Detailed Description:
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:
- Male of Female aged 18‐65 years.
- Persistent allergic rhinitis with or without asthma.
- Atopy to at least one allergen on SPT.
- Ability to give a written informed consent.
- Ability and willingness to comply with the requirements of the protocol.
Exclusion Criteria:
- Recent respiratory tract/sinus infection within the last 2 months. .
- Pregnancy, planned pregnancy or lactation.
- Known or suspected hypersensitivity to any of the IMP's.
- Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may interfere with the trial.
- Nasal Polyposis grade 2+, Deviated nasal septum ≥ 50%
- The use of oral corticosteroids within the last 3 months.
Contacts and Locations| United Kingdom | |
| Ninewells Hospital and Medical School | |
| Dundee, United Kingdom, DD1 9SY | |
| Perth Royal Infirmary | |
| Perth, United Kingdom, PH1 1NX | |
| Principal Investigator: | Sriram Vaidyanathan, MBBS | University of Dundee |
| Study Director: | Brian Lipworth, MD, FRCP | University of Dundee |
More Information
Publications:
| Responsible Party: | Brian J Lipworth, Professor, University of Dundee |
| ClinicalTrials.gov Identifier: | NCT00845598 History of Changes |
| Other Study ID Numbers: | VAI04 |
| Study First Received: | February 17, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Dundee:
|
Allergic Rhinitis |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013