Azelastine Fluticasone Combination vs. Fluticasone

This study has been withdrawn prior to enrollment.
(Could not get IMP)
Sponsor:
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
ClinicalTrials.gov Identifier:
NCT00845598
First received: February 17, 2009
Last updated: June 11, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845598

Locations
United Kingdom
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Perth Royal Infirmary
Perth, United Kingdom, PH1 1NX
Sponsors and Collaborators
University of Dundee
Investigators
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 July 24, 2014