Azelastine Fluticasone Combination vs. Fluticasone

June 11, 2012 updated by: Brian J Lipworth, University of Dundee

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Perth, United Kingdom, PH1 1NX
        • Perth Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fluticasone propionate
Drug: Fluticasone propionate
Fluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
60 minute recovery to AMP challenge
Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Mini RQLQ
Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Global visual analogue scale
Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Nasal lavage for cytokines
Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Overnight urinary cortisol creatinine ratio
Time Frame: 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Domiciliary diary cards
Time Frame: 2 week treatment periods
2 week treatment periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: Sriram Vaidyanathan, MBBS, University of Dundee
  • Study Director: Brian Lipworth, MD, FRCP, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

June 12, 2012

Last Update Submitted That Met QC Criteria

June 11, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAI04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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