Azelastine Fluticasone Combination vs. Fluticasone

NCT00845598 | Withdrawn Phase 4

• 1 other identifier: VAI04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Maximum percentage fall in PNIF after 400mg/ml of AMP nasal challenge between both groups.

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary Outcomes (6)

• 60 minute recovery to AMP challenge

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

• Mini RQLQ

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

• Global visual analogue scale

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

• Nasal lavage for cytokines

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

• Overnight urinary cortisol creatinine ratio

  0, 2 weeks, 4 weeks, 6 weeks, 8 weeks

Study Arms (2)

Azelastine Fluticasone

EXPERIMENTAL

Drug: Azelastine , fluticasone

Fluticasone propionate

ACTIVE COMPARATOR

Drug: Fluticasone propionate

Interventions

Azelastine , fluticasone DRUG

Azelastine Hydrochloride BP 0.10% w/v AND Fluticasone propionate BP 0.0357% w/v as combination 1 squirt in each nostril twice daily

Azelastine Fluticasone

Fluticasone propionate DRUG

Fluticasone propionate 0.05% w/w 2 squirts in each nostril (50 μg per squirt)

Fluticasone propionate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (2)

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

Perth Royal Infirmary

Perth, PH1 1NX, United Kingdom

Location

Related Publications (8)

• Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.

  PMID: 11707753 BACKGROUND

• Nassef M, Shapiro G, Casale TB; Respiratory and Allergic Disease Foundation. Identifying and managing rhinitis and its subtypes: allergic and nonallergic components--a consensus report and materials from the Respiratory and Allergic Disease Foundation. Curr Med Res Opin. 2006 Dec;22(12):2541-8. doi: 10.1185/030079906x158057.

  PMID: 17265594 BACKGROUND

• Nolte H, Nepper-Christensen S, Backer V. Unawareness and undertreatment of asthma and allergic rhinitis in a general population. Respir Med. 2006 Feb;100(2):354-62. doi: 10.1016/j.rmed.2005.05.012. Epub 2005 Jul 11.

  PMID: 16005621 BACKGROUND

• Gupta R, Sheikh A, Strachan DP, Anderson HR. Burden of allergic disease in the UK: secondary analyses of national databases. Clin Exp Allergy. 2004 Apr;34(4):520-6. doi: 10.1111/j.1365-2222.2004.1935.x.

  PMID: 15080802 BACKGROUND

• Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis: systematic review of randomised controlled trials. BMJ. 1998 Dec 12;317(7173):1624-9. doi: 10.1136/bmj.317.7173.1624.

  PMID: 9848901 BACKGROUND

• Meltzer EO, Weiler JM, Dockhorn RJ, Widlitz MD, Freitag JJ. Azelastine nasal spray in the management of seasonal allergic rhinitis. Ann Allergy. 1994 Apr;72(4):354-9.

  PMID: 7908778 BACKGROUND

• Newson-Smith G, Powell M, Baehre M, Garnham SP, MacMahon MT. A placebo controlled study comparing the efficacy of intranasal azelastine and beclomethasone in the treatment of seasonal allergic rhinitis. Eur Arch Otorhinolaryngol. 1997;254(5):236-41. doi: 10.1007/BF00874095.

  PMID: 9195148 BACKGROUND

• Berger WE, Fineman SM, Lieberman P, Miles RM. Double-blind trials of azelastine nasal spray monotherapy versus combination therapy with loratadine tablets and beclomethasone nasal spray in patients with seasonal allergic rhinitis. Rhinitis Study Groups. Ann Allergy Asthma Immunol. 1999 Jun;82(6):535-41. doi: 10.1016/s1081-1206(10)63161-4.

  PMID: 10400480 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

azelastine; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sriram Vaidyanathan, MBBS

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Brian Lipworth, MD, FRCP

  University of Dundee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 18, 2009
• Study Start: August 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

GB (2)