The effect of inhaled steroid on the Na+/K+ pumps in muscle tissue

The effect of inhaled glucocorticoids on the content of Na+/K+ pumps in human skeletal muscle

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002932-15-DK

Enrollment

Unknown

Registered

2014-07-14

Start date

2014-09-10

Completion date

Unknown

Last updated

2016-06-27

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

Conditions

Asthma MedDRA version: 17.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Spirocort Pharmaceutical Form: Inhalation powder INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Current Sponsor code: 43895 Other descriptive name: 16a,17-[(1RS)-butylidenebis(oxy)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Physically inactive healthy men, 18-40 years - Informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Smoking or former smoker. Chronic diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary To examine whether the content of Na+, K+ pumps in skeletal muscle is upregulated after two weeks of daily inhaled glucocorticoid. ;Secondary Objective: Secondary To examine whether the levels of plasma K+ at rest and during exercise are affected by upregulation of Na+, K+ pumps To examine whether the endurance during exercise is affected by upregulation of Na+, K+ pumps ;Primary end point(s): Content of Na+, K+ pumps in the striated muscles, as judged by the content of (3 H) ouabain binding sites. ;Timepoint(s) of evaluation of this end point: After two weeks of daily inhalation of budesonide	—

Measure

Time frame

Main Objective: Primary To examine whether the content of Na+, K+ pumps in skeletal muscle is upregulated after two weeks of daily inhaled glucocorticoid. ;Secondary Objective: Secondary To examine whether the levels of plasma K+ at rest and during exercise are affected by upregulation of Na+, K+ pumps To examine whether the endurance during exercise is affected by upregulation of Na+, K+ pumps ;Primary end point(s): Content of Na+, K+ pumps in the striated muscles, as judged by the content of (3 H) ouabain binding sites. ;Timepoint(s) of evaluation of this end point: After two weeks of daily inhalation of budesonide

—

Secondary

Measure	Time frame
Secondary end point(s): - Plasma K+ at rest, after beta-2 agonist stimulation and during and after exercise. - Endurance (Bike test at 90% of Wmax; time to exhaustion) ;Timepoint(s) of evaluation of this end point: After two weeks of daily inhalation of budesonide	—

Countries

Denmark

Contacts

Public ContactRespiratory Research Unit

Bispebjerg University Hospital

celeste.porsbjerg@regionh.dk

Outcome results

None listed

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