NCT06105671

Brief Summary

The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

October 23, 2023

Last Update Submit

August 12, 2024

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

  • Power output during time trial

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

    Through study completion, an average on 4 weeks

Secondary Outcomes (1)

  • Power output during sprint testing

    Through study completion, an average on 4 weeks

Other Outcomes (3)

  • Quadriceps strength

    Through study completion, an average on 4 weeks

  • Forced Expiratory Volume in 1 second (FEV1)

    Through study completion, an average on 4 weeks

  • Respiratory muscle function

    Through study completion, an average on 4 weeks

Study Arms (5)

Symbicort - usual care

EXPERIMENTAL

Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

Drug: Symbicort

Formoterol - inhalation

EXPERIMENTAL

Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

Drug: Formoterol

Formoterol - oral

EXPERIMENTAL

Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.

Drug: Formoterol

Placebo

PLACEBO COMPARATOR

Participants are administered placebo from an inhaler device testing and a placebo capsule.

Drug: Placebo

Mannitol-test

EXPERIMENTAL

Participants are administered Bronchitol from an inhaler device testing.

Drug: Mannitol

Interventions

SymbicortDRUG

Participants are administered 54 μg Formoterol and 1920 μg Budesonide

Symbicort - usual care
FormoterolDRUG

Participants are administered 54 μg Formoterol from an inhaler device

Formoterol - inhalation
PlaceboDRUG

Participants are administered placebo

Placebo
MannitolDRUG

Participants are administered 600 mg Bronchitol

Mannitol-test

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-45
  • Physically active \>5 hours a week
  • Maximum oxygen uptake classified as high or very high

You may not qualify if:

  • Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
  • ECG abnormality
  • FEV1/FVC ratio \< 0,7 determined with spirometry
  • Chronic illness determined to be a potential risk for participant during the study
  • In chronic treatments with medication that may interfere with study results
  • Pregnancy
  • Smoker
  • Blood donation during the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Budesonide, Formoterol Fumarate Drug CombinationFormoterol FumarateMannitol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsSugar AlcoholsCarbohydrates

Study Officials

  • Morten Hostrup, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 30, 2023

Study Start

January 5, 2024

Primary Completion

July 4, 2024

Study Completion

July 4, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

DK(1)