The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma

2016-003509-33

This study aims to assess the effect of inhaled corticosteroids (ICS) on airway smooth muscle (ASM) Na+, K+ pumps in patients with asthma.We wish to investigate differences in Na+, K+ pump content in healthy versus asthmatic patients, whether a reduction in airway hyper-responsiveness observed in asthmatic patients treated with ICS is attributable to an increase in Na+, K+ pump content in ASM cells and compare this in patients with non-eosinophilic asthma versus eosinophilic asthma.

2017-03-27

2019-02-28

2019-02-28

Completed

Early phase I

60

Inclusion Criteria: * Asthma as defined by GINA (www.ginasthma.org) Eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) \> 25 ppb (marker of eosinophilic airway inflammation) Non-eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) \< 25 ppb * An FEV1 value of ≥70% of expected * Airway hyperresponsiveness to mannitol (PD15 ≤ 315 mg) * Not treated with oral or inhaled steroids (past 3 months) Exclusion Criteria: * Smoking (current smokers or a maximum of 10 pack years) * Competing respiratory diseases * Lower respiratory tract infection within the past 4 weeks * Medical history with significant comorbidity (ASA\>2) * Pregnant or breastfeeding * Hypersensitivity to study medication including Spirocort, Osmohale, Midazolam or Fentanyl * Uncontrolled hypertension * Acute myocardial infarction within past 6 months * Aorta- or cerebral aneurism * Recent abdominal operation * Failure to comply with study protocol

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2023-02-10