At a glance
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A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis
In Brief
A Phase 4 clinical trial evaluating Fluticasone Evohaler pMDI, Placebo, and 3 other interventions for Asthma and Allergic Rhinitis. Completed, enrolled 25 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)
1 puff of inhaled Placebo twice a day
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)
placebo intranasal spray 2 squirts each nostril once a day
intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts