NCT00903227

Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

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

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2009-05-18
• Last updated: 2019-10-16

Locations

1 site across 1 country: United Kingdom