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Role of Lung Function for Exercise Capacity in Well-trained Individuals

ConditionExercise Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorMorten Hostrup, PhD

About this trial

The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-39

Physically active > 5 h weekly

Maximal oxygen consumption classified as high or very high

Disqualifiers

Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid

ECG abnormality

ACQ score > 1.5

Severe bronchial hyperreactivity as determined by mannitol test

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vilanterol and Fluticasone Furoate

    Drug

    Participants inhale 25 µg vilanterol + fluticasone furoate daily

  • Indacaterol and Mometasone Furoate

    Drug

    Participants inhale 125 µg indacaterol + mometasone furoate daily

  • Placebo

    Drug

    Participants inhale placebo daily

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: VilanterolExperimental treatment 1 intervention
Group B: IndacaterolExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise capacity during a time trial

Mean power output measured in Watts during a time trial on a bike ergometer

Time frame
Through study completion, an average of 8 weeks

Secondary outcomes

1

Lung function

Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation

Time frame
Through study completion, an average of 8 weeks

Other outcomes

1

Airway inflammation

Measured by fractional nitric oxide in expired air

Time frame
Through study completion, an average of 8 weeks
2

Mannitol induced bronchial hyper reactivity

Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol

Time frame
Through study completion, an average of 8 weeks
3

Exercise induced bronchial hyper reactivity

Assessed by decreases in FEV1 after maximal exercise

Time frame
Through study completion, an average of 8 weeks
4

Quadriceps muscle strength

Assessed by maximal isometric contraction torque

Time frame
Through study completion, an average of 8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Morten Hostrup, PhD

Lead sponsor

University of Copenhagen

Sponsor institution

Source ClinicalTrials.gov
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