The RECONSTRUCT Study - Reconstructing Disease Mechanisms in Asthma

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bispebjerg Hospital
• Treatments: Budesonide

Criteria

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