U-LABA/ICS Effects on Exercise Performance, Vilanterol

Sponsor

Morten Hostrup, PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT06066606

Collaborator

(none)

Enrollment

Location

Arms

25.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate

Condition or Disease	Intervention/Treatment	Phase
Exercise Performance	Drug: Vilanterol and Fluticasone Furoate (low dose) Drug: Vilanterol and Fluticasone Furoate (high dose) Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol

Anticipated Study Start Date :

Oct 5, 2023

Anticipated Primary Completion Date :

Sep 15, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vilanterol + fluticasone furoate Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing	Drug: Vilanterol and Fluticasone Furoate (low dose) Participants are administered 25 µg of vilanterol + fluticasone furoate Drug: Vilanterol and Fluticasone Furoate (high dose) Participants are administered 100 µg of vilanterol + fluticasone furoate
Placebo Comparator: Placebo Participants are administered placebo from an inhaler device testing	Drug: Placebo Participants are administered placebo

Arm

Intervention/Treatment

Experimental: Vilanterol + fluticasone furoate

Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing

Drug: Vilanterol and Fluticasone Furoate (low dose)

Participants are administered 25 µg of vilanterol + fluticasone furoate

Drug: Vilanterol and Fluticasone Furoate (high dose)

Participants are administered 100 µg of vilanterol + fluticasone furoate

Placebo Comparator: Placebo

Participants are administered placebo from an inhaler device testing

Drug: Placebo

Participants are administered placebo

Outcome Measures

Primary Outcome Measures

Power output during sprint testing [Through study completion, an average of 3 weeks]
Power output measured in Watts during a sprint on a bike ergometer

Secondary Outcome Measures

Power output during time trial [Through study completion, an average of 3 weeks]
Mean power output measured in Watts during a time trial on a bike ergometer

Other Outcome Measures

Forced Expiratory Volume in 1 second (FEV1) [Through study completion, an average of 3 weeks]
FEV1 measured by spirometry
Quadriceps strength [Through study completion, an average of 3 weeks]
Maximal torque (Nm) achieved during isometric contraction
Respiratory muscle function [Through study completion, an average of 3 weeks]
Mouth inspiratory and expiratory pressures against a closed system

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	August Krogh Building	Copenhagen	DK	Denmark	2100

Sponsors and Collaborators

Morten Hostrup, PhD

Investigators

Principal Investigator: Morten Hostrup, PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Hostrup, PhD, Associate Professor, University of Copenhagen

ClinicalTrials.gov Identifier:

NCT06066606

Other Study ID Numbers:

First Posted:

Oct 4, 2023

Last Update Posted:

Oct 4, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fluticasone

Xhance

Study Results

No Results Posted as of Oct 4, 2023