Allergy Clinical Trial
Official title:
Proof of Concept Study to Assess Downstream Effects of Using Combined Intranasal Fluticasone Propionate Plus Azelastine Nasal Spray on Asthmatic Inflammation in Patients With Persistent Asthma and Allergic Rhinitis
Single centre, double-blind, placebo controlled, adaptive design, cross-over trial. The primary objective is to assess the additive effects of using combined intranasal fluticasone propionate plus azelastine nasal spray on airway hyperresponsiveness. This is in patients with persistent asthma and allergic rhinitis, receiving inhaled steroid.
The unified allergic airway describes patients who have both asthma and allergic rhinitis.
Both conditions have similar underlying pathophysiology in terms of T-helper 2 (Th2) cell
activation. Patients with unified allergic airway disease have a greater burden in terms of
impaired quality of life, and the presence of airway hyper-responsiveness (AHR) to
methacholine is a hallmark of their underlying asthmatic inflammatory process. Targeting the
Th2 allergic airway with a topical antihistamine may improve airway hyperresponsiveness.
It has previously been shown that in patients with unified allergic airway disease, using
inhaled fluticasone alone (100 micrograms per day) produced a 1.2 doubling dilution (dd)
shift in the provocative concentration of methacholine required to reduce forced expiratory
volume (FEV1) by 20% (PC20). However when adding nasal fluticasone to the inhaled steroid,
there was a 1.79 dd shift. This difference (0.58 dd, 95% CI 0.78, 1.95) was not statistically
significant. However the combined treatment did result in significant improvement in rhinitis
quality of life, nasal inflammation and inspiratory flow.
The investigators will repeat this previous concept, but compare intranasal fluticasone with
azelastine (an antihistamine) nasal spray versus placebo nasal spray, in atopic asthmatic
patients on inhaled steroid. This will be to assess effects on methacholine PC20, the primary
outcome, and to assess the effects on the following secondary outcomes: Exhaled nitric oxide
(FeNO), FEV1, morning peak expiratory flow (PEF), impulse oscillometry, peak nasal
inspiratory flow (PNIF), nasal nitric oxide (NO), blood eosinophils, eosinophilic cationic
protein (ECP), nasal symptoms, asthma control and quality of life; and rhinitis quality of
life.
Twenty adults 18 and up, with allergic asthma will be enrolled. They will have a run-in on 2
weeks of 200 micrograms beclometasone inhaler and then be randomised to add either intranasal
fluticasone and azelastine, or placebo nasal spray to their treatment (double blind).
Treatment period one will be 3-5 weeks followed by a washout of 2-4 weeks, and crossover to
treatment period two for 3-5 weeks. Due to the crossover nature of this study participants
will receive both treatments in random order. There will be an Interim analysis after 20
participants complete the study per protocol and the exact required sample size will be
recalculated (Pocock/adaptive design).
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