CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Fluticasone Evohaler pMDI +4 moredrug
Likely dose
Fluticasone Evohaler pMDI 50 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00903227
NCT00903227Phase 4Completed

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

University of Dundee·interventional·Posted May 18, 2009·Updated Oct 16, 2019

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 18, 2009
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.1 years ago

Interventions

Fluticasone Evohaler pMDIdrug

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

Placebodrug

1 puff of inhaled Placebo twice a day

Fluticasone Evohalerdrug

One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

Placebo intranasal spraydrug

placebo intranasal spray 2 squirts each nostril once a day

fluticasone propionate (Flixonase®)drug

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts