U-LABA/ICS Effects on Exercise Performance, Indacaterol

• Sponsor: Morten Hostrup, PhD (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06067100
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.9
• Patients Per Site Per Month: 1.2

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 indacaterol + mometasonefuroate

Condition or Disease	Intervention/Treatment	Phase
Exercise Performance	Drug: Indacaterol and Mometasonefluroate (low dose); Drug: Placebo; Drug: Indacaterol and Mometasonefluroate (high dose)	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, Indacaterol
• 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: 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
Placebo Comparator: Placebo	Drug: Placebo; Participants are administered placebo

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Forced Expiratory Volume in 1 second (FEV1) [Through study completion, an average of 3 weeks]

   FEV1 measured by spirometry

3. Quadriceps strength [Through study completion, an average of 3 weeks]

   Maximal torque (Nm) achieved during isometric contraction

4. Respiratory muscle function [Through study completion, an average of 3 weeks]

   Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter)

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		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: NCT06067100
• Other Study ID Numbers: INDAC
• First Posted: Oct 4, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 10, 2023