Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Asthma Clinical Trial

Official title:

A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903227
• Other study ID #: NAI03
• Secondary ID: 2005-005557-22
• Status: Completed
• Phase: Phase 4
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: October 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Mild to moderate atopic asthmatics with FEV1 = 60% on = 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 < 4 mg/ml)

• Male or female aged 18-65 years

• Informed Consent

• Ability to comply with the requirements of the protocol

Exclusion Criteria:

• Severe asthmatics as defined by an FEV1 = 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.

• Nasal Polyposis grade 2/3, deviated nasal septum = 50%

• The use of oral corticosteroids within the last 3 months

• Recent respiratory tract infection (2 months)

• Significant concomitant respiratory disease

• Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol

• Any significant abnormal laboratory result as deemed by the investigators

• Pregnancy, planned pregnancy or lactation

• Known or suspected contra-indication to any of the IMP's

• Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Fluticasone Evohaler pMDI
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
• Placebo
1 puff of inhaled Placebo twice a day
• Fluticasone Evohaler
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)
• Placebo intranasal spray
placebo intranasal spray 2 squirts each nostril once a day
• fluticasone propionate (Flixonase®)
intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee	Dundee	Angus

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Bousquet J, Reid J, van Weel C, Baena Cagnani C, Canonica GW, Demoly P, Denburg J, Fokkens WJ, Grouse L, Mullol K, Ohta K, Schermer T, Valovirta E, Zhong N, Zuberbier T. Allergic rhinitis management pocket reference 2008. Allergy. 2008 Aug;63(8):990-6. doi: 10.1111/j.1398-9995.2008.01642.x. — View Citation

Corren J. Allergic rhinitis and asthma: how important is the link? J Allergy Clin Immunol. 1997 Feb;99(2):S781-6. Review. — View Citation

Dahl R, Nielsen LP, Kips J, Foresi A, Cauwenberge P, Tudoric N, Howarth P, Richards DH, Williams M, Pauwels R; SPIRA Study Group. Intranasal and inhaled fluticasone propionate for pollen-induced rhinitis and asthma. Allergy. 2005 Jul;60(7):875-81. — View Citation

Nair A, Vaidyanathan S, Clearie K, Williamson P, Meldrum K, Lipworth BJ. Steroid sparing effects of intranasal corticosteroids in asthma and allergic rhinitis. Allergy. 2010 Mar;65(3):359-67. doi: 10.1111/j.1398-9995.2009.02187.x. Epub 2009 Oct 5. Erratum — View Citation

Reed CE, Marcoux JP, Welsh PW. Effects of topical nasal treatment on asthma symptoms. J Allergy Clin Immunol. 1988 May;81(5 Pt 2):1042-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	methacholine PC20		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Spirometry		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Juniper AQLQ		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Fractionated Nitric Oxide		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	serum ECP		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	blood eosinophils		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Overnight urinary cortisol creatinine		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Peak Nasal Inspiratory Flow rate		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Nasal Nitric Oxide		0, 2, 4, 6, 8, 10, 12 weeks
Secondary	Juniper mini RQLQ		0, 2, 4, 6, 8, 10, 12 weeks