Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma

University of Dundee15 enrolled

Overview

The purpose of this study is to establish whether addition of extra-fine particle steroid inhalers achieve additional suppression of small airways inflammation when added to 'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

HFA-BDPDRUG

HFA-BDP (Qvar) 100ug 2puff b.i.d

FluticasoneDRUG

Fluticasone propionate Accuhaler 250ug b.i.d.

SeretideDRUG

Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Refractory, non-smoking asthmatics with FEV1 les than 80% predicted * RV greater than 100% predicted and CANO greater than 3ppb when stepped up to 1000µg of fluticasone per day, with or without additional asthma medication. * Informed consent and ability to perform exhaled nitric oxide assessment. * Participants must be on greater than 500mcg of fluticasone per day to enter dose ramp run-in. Exclusion Criteria: * Recent respiratory infection or oral steroid use. * Pregnancy or lactation. * Known or suspected contra-indication to any of the IMP's. * CANO less than 3ppb, FEV1 greater than 80% or RV less than 100% at post-optimisation visit.

Locations (1)

Asthma and Allergy Research Group, Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Outcomes

Primary Outcomes

Alveolar nitric oxide

Time frame: 16 weeks

Data from ClinicalTrials.gov

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