NCT03034005

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 asthma

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

January 25, 2017

Last Update Submit

February 9, 2023

Conditions

Asthma

Keywords

Inhaled corticosteroidsAirway hyper-responsivenessAirway smooth musclesodium-potassium pump

Outcome Measures

Primary Outcomes (1)

  • Change in airway hyperresponsiveness (mannitol challenge) per change in Na+, K+ pumps content in airway smooth muscle.

    Change in PD15 per chhange in NA/K ATP'ase content

    6 weeks

Secondary Outcomes (2)

  • Change in Na+, K+ pump content in airway smooth muscle and in skeletal muscle (ρmol ouabain per g wet weight) in NEA vs. EA.

    6 weeks

  • Change in airway hyperresponsiveness (PD15 to mannitol) in NEA vs. EA

    6 weeks

Other Outcomes (4)

  • Change in asthma control score vs in Na+, K+ pumps content in airway smooth muscle.

    6 weeks

  • Change in lung function (FEV1) vs in Na+, K+ pumps content in airway smooth muscle

    6 weeks

  • Change in asthma control score in NEA vs. EA

    6 weeks

  • +1 more other outcomes

Study Arms (2)

Patients with asthma

EXPERIMENTAL

6 weeks treatment with 1600 ug budesonide

Drug: Budesonide

Healthy Controls

NO INTERVENTION

Healthy controls to establish baseline level of Na/K pumps.

Interventions

BudesonideDRUG

1600 ug inhaled daily for 6 weeks

Also known as: Pulmicort
Patients with asthma

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lungemedicinsk forskningsenhed, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Celeste Porsbjerg

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

March 27, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)