To investigate the effects of the inhaled beta-agonists salbutamol or formoterol (or in combination) in lung-healthy male and female competitive athletes on performance in a 10min maximal all-out-trial on a cycle ergometer, the effects on cardiopulmonary function, myocardial function and contractility as well as on the muscular transcription of anabolic pathways after exercise, in particular of the transcription factors NR4A1, NR4A2, NR4A3 as well as an analysis of the transcriptome (Clariom-S-C
Conditions
Interventions
Group 1: The potential effects of beta-2-agonists will be tested in-vivo in a randomized, double blinded, balanced four-way cross-over study with healthy, non-AHR male (n=12) and female (n=12) enduran
Sponsors
Universitätsklinikum Ulm, Kliniken am oberen Eselsberg
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: • Age: 18 to 45 years, very good endurance capacity (VO2 max >52 ml / kg / min for male participants, > 42 ml / kg / min for female participants) • able to sign a consent form
Exclusion criteria
Exclusion criteria: 1. Sex and reproductive status: - Women of childbearing potential (WOCBP) who are unwilling or unable to use highly effective birth control methods preferably with low user dependency (see Chapter 9. Methods to ensure safety). Men are do not have to use birth control methods during participation in the study. - Women who are pregnant or breastfeeding or are planning pregnancy during course of trial - Women with a positive pregnancy test on enrolment or prior to investigational product administration 2. Allergy - History of hypersensitivity, contraindication or (serious) adverse reaction of any component of the trial medication; i.e.: - Formoterolfumarat-dihydrate, - Salbutamol-sulfate, - Lactose, - Lactose-monohydrate, - Methacholine-chlorid, or any other cholinergic medication/parasympatomimetic drug - Natriummonohydrogenphosphate-dihydrate, - Natriumhydrogenphosphate-monohydrate - Milk protein - Symptomatic hay fever - Galactose intolerance 3. Medical history and concurrent disease: - History of bleeding diathesis or active bleeding within the last 30 days - Patients with an indication for anticoagulant therapy or chronic intake of any anticoagulant therapy - Any coagulopathy (coagulation testing: INR > 1,5, PTT has to be within the normal range limit according to laboratory testing) - Thrombocytopenia (platelet count 2-fold the upper normal range limit) - Mild kidney dysfunction (estimated glomerular filtration rate 140 mmHg or diastolic BP > 90 mmHg) and Sinus-tachycardia (> 100 bpm) at screening - Medically treated arterial hypertension (e. g. use of ß-blockers, ACE-inhibitors, calcium antagonists, diuretics, etc.) - Severe hypotension (systolic BP < 90 mmHg or diastolic < 50 mmHg) at screening - Intake of any medication** (e. g. tricyclic antidepressants, MAO inhibitors, steroids, diuretics, digitalis glycosides, anti-rheumatic drug, anti-cholinergic drug, methylxanthine, etc.) which could influence the results or increase the risk of side effects of the trial medication - Any planned surgery using halogenated anesthetics during course of trial - Lactase deficiency - Glucose-galactose malab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time trial test (VO2peak; Average power and peak power during time trial) 2. Muscular expression of metabolic signaling (NR4a 1/2/3) at time point 3 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Circulating hormones levels - Urine and plasma concentrations of salbutamol and formoterol - Circulating cardiac markers - Cardiopulmonary function | — |
Countries
Germany
Contacts
Public ContactJürgen Michael Steinacker
Klinik für Innere Medizin II Sektion Sport- und Rehabilitationsmedizin
Outcome results
None listed