U-LABA/ICS Effects on Exercise Performance, Indacaterol

October 4, 2023 updated by: Morten Hostrup, PhD

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Participants are administered placebo
Experimental: Indacaterol + mometasonefluroate
Drug: Indacaterol and Mometasonefluroate (low dose)
Participants are administered 125 µg indacaterol + mometasonefluroate
Drug: Indacaterol and Mometasonefluroate (high dose)
Participants are administered 500 µg indacaterol + mometasonefluroate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power output during sprint testing
Time Frame: Through study completion, an average of 3 weeks
Power output measured in Watts during a sprint on a bike ergometer
Through study completion, an average of 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power output during time trial
Time Frame: Through study completion, an average of 3 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
Through study completion, an average of 3 weeks
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: Through study completion, an average of 3 weeks
FEV1 measured by spirometry
Through study completion, an average of 3 weeks
Quadriceps strength
Time Frame: Through study completion, an average of 3 weeks
Maximal torque (Nm) achieved during isometric contraction
Through study completion, an average of 3 weeks
Respiratory muscle function
Time Frame: Through study completion, an average of 3 weeks
Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter)
Through study completion, an average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morten Hostrup, PhD

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • INDAC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exercise Performance

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe