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

NCT00903227 Phase 4 COMPLETED

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.

Details

Lead sponsor	University of Dundee
Phase	Phase 4
Status	COMPLETED
Enrolment	25
Start date	2006-12
Completion	2008-08

Conditions

• Asthma
• Allergic Rhinitis

Interventions

• Fluticasone Evohaler pMDI
• Placebo
• Fluticasone Evohaler
• Placebo intranasal spray
• fluticasone propionate (Flixonase®)

Primary outcomes

• methacholine PC20 — 0, 2, 4, 6, 8, 10, 12 weeks

Countries

United Kingdom