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

Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals

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

Study Overview

• Status: Recruiting
• Conditions: Exercise Performance
• Intervention / Treatment: Drug: Vilanterol and Fluticasone Furoate; Drug: Indacaterol and Mometasone Furoate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morten Hostrup, PhD; Phone Number: +4535321595; Email: mhostrup@nexs.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • August Krogh Building
    • Contact: Morten Hostrup, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-39
• Physically active > 5 h weekly
• Maximal oxygen consumption classified as high or very high

Exclusion Criteria:

• 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
• FEV1/FVC ratio < 0.7 determined with spirometry
• Chronic illness determined to be a potential risk for participant during study
• In chronic treatment with medication that may interfere with study results
• Pregnancy
• Smoker
• Blood donation during the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vilanterol; Participants inhale vilanterol + fluticasone furoat	Drug: Vilanterol and Fluticasone Furoate; Participants inhale 25 µg vilanterol + fluticasone furoate daily
Experimental: Indacaterol; Participants inhale indacaterol + mometasone furoate	Drug: Indacaterol and Mometasone Furoate; Participants inhale 125 µg indacaterol + mometasone furoate daily
Placebo Comparator: Placebo; Participants inhale placebo	Drug: Placebo; Participants inhale placebo daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity during a time trial	Mean power output measured in Watts during a time trial on a bike ergometer	Through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation	Through study completion, an average of 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway inflammation	Measured by fractional nitric oxide in expired air	Through study completion, an average of 8 weeks
Mannitol induced bronchial hyper reactivity	Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol	Through study completion, an average of 8 weeks
Exercise induced bronchial hyper reactivity	Assessed by decreases in FEV1 after maximal exercise	Through study completion, an average of 8 weeks
Quadriceps muscle strength	Assessed by maximal isometric contraction torque	Through study completion, an average of 8 weeks
Lean body mass	Measured with DXA-scanning	Through study completion, an average of 8 weeks
Fat mass	Measured with DXA-scanning	Through study completion, an average of 8 weeks

Collaborators and Investigators

• Sponsor: Morten Hostrup, PhD
• Investigators: Principal Investigator: Morten Hostrup, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): October 5, 2023
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance; Mometasone Furoate
• Other Study ID Numbers: CHRON_INDAC_VIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data set will be shared upon reasonable request.
• IPD Sharing Time Frame: Deidentified data set will be shared upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No