U-LABA/ICS Effects on Exercise Performance, Formoterol

Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

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.

Study Overview

• Status: Completed
• Conditions: Exercise Performance
• Intervention / Treatment: Drug: Placebo; Drug: Symbicort; Drug: Formoterol; Drug: Mannitol; Drug: Formoterol

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • August Krogh Building

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symbicort - usual care; Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.	Drug: Symbicort; Participants are administered 54 μg Formoterol and 1920 μg Budesonide
Experimental: Formoterol - inhalation; Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.	Drug: Formoterol; Participants are administered 54 μg Formoterol from an inhaler device; Drug: Formoterol; Participants are administered 120 μg Formoterol in a capsule, which is taken orally
Experimental: Formoterol - oral; Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.	Drug: Formoterol; Participants are administered 54 μg Formoterol from an inhaler device; Drug: Formoterol; Participants are administered 120 μg Formoterol in a capsule, which is taken orally
Placebo Comparator: Placebo; Participants are administered placebo from an inhaler device testing and a placebo capsule.	Drug: Placebo; Participants are administered placebo
Experimental: Mannitol-test; Participants are administered Bronchitol from an inhaler device testing.	Drug: Mannitol; Participants are administered 600 mg Bronchitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Power output during sprint testing	Power output measured in Watts during a sprint on a bike ergometer	Through study completion, an average on 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps strength	Maksimal torque (Nm) achieved during isometric contraction	Through study completion, an average on 4 weeks
Forced Expiratory Volume in 1 second (FEV1)	FEV1 measured by spirometry	Through study completion, an average on 4 weeks
Respiratory muscle function	Mouth inspiratory and expiratory pressures against a closed system	Through study completion, an average on 4 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 (Actual): January 5, 2024
• Primary Completion (Actual): July 4, 2024
• Study Completion (Actual): July 4, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Mannitol; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: FOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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