The RECONSTRUCT study Reconstructing Disease Mechanisms in Asthma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003509-33-DK

Enrollment

Registered

2016-09-06

Start date

2016-11-30

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Spirocort turbohaler 400 ug Product Name: Spirocort turbohaler 400 ug Pharmaceutical Form: Inhalation powder INN or Proposed INN: BUDESONIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Asthma as defined by GINA (www.ginasthma.org) o Eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) > 25 ppb (marker of eosinophilic airway inflammation) o Non-eosinophilic asthma: Fractional exhaled nitric oxide (FeNO) =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 • Failure to comply with study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the correlation between increase in ASM content of Na+, K+ pumps and reduction in airway hyperresponsiveness to mannitol after six weeks of daily inhalation of glucocorticoid, in patients with asthma and to describe differences in ASM content of Na+, K+ pumps among healthy subjects and patients with non-eosinophilic asthma (NEA) or eosinophilic asthma (EA) respectively. Primary endpoint: ; Secondary Objective: Not applicable ;Primary end point(s): • Change in airway hyperresponsiveness (mannitol challenge) per change in Na+, K+ pumps content in airway smooth muscle.;Timepoint(s) of evaluation of this end point: december 31 2018	—

Measure

Time frame

Main Objective: To describe the correlation between increase in ASM content of Na+, K+ pumps and reduction in airway hyperresponsiveness to mannitol after six weeks of daily inhalation of glucocorticoid, in patients with asthma and to describe differences in ASM content of Na+, K+ pumps among healthy subjects and patients with non-eosinophilic asthma (NEA) or eosinophilic asthma (EA) respectively. Primary endpoint: ; Secondary Objective: Not applicable ;Primary end point(s): • Change in airway hyperresponsiveness (mannitol challenge) per change in Na+, K+ pumps content in airway smooth muscle.;Timepoint(s) of evaluation of this end point: december 31 2018

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Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives: • Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (?mol ouabain per g wet weight) in patients with NEA vs. (EA). • Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA. Exploratory objectives: • Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle • Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle • Change in asthma control score in NEA vs. EA • Change in lung function (FEV1) in NEA vs. EA ;Timepoint(s) of evaluation of this end point: december 31 2018	—

Measure

Time frame

Secondary end point(s): Secondary objectives: • Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (?mol ouabain per g wet weight) in patients with NEA vs. (EA). • Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA. Exploratory objectives: • Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle • Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle • Change in asthma control score in NEA vs. EA • Change in lung function (FEV1) in NEA vs. EA ;Timepoint(s) of evaluation of this end point: december 31 2018

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Countries

Denmark

Contacts

Public ContactLungemedicinsk Forskningsenhed

Lungemedicinsk Forskningsenhed, Bispebjerg Hospital

celeste.porsbjerg@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026