Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06067100
Other study ID # INDAC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2023
Est. completion date December 1, 2025

Study information

Verified date October 2023
Source University of Copenhagen
Contact Morten Hostrup, PhD
Phone +4535321595
Email mhostrup@nexs.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2025
Est. primary completion date September 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Indacaterol and Mometasonefluroate (low dose)
Participants are administered 125 µg indacaterol + mometasonefluroate
Placebo
Participants are administered placebo
Indacaterol and Mometasonefluroate (high dose)
Participants are administered 500 µg indacaterol + mometasonefluroate

Locations

Country Name City State
Denmark August Krogh Building Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Power output during sprint testing Power output measured in Watts during a sprint on a bike ergometer Through study completion, an average of 3 weeks
Secondary Power output during time trial Mean power output measured in Watts during a time trial on a bike ergometer Through study completion, an average of 3 weeks
Secondary Forced Expiratory Volume in 1 second (FEV1) FEV1 measured by spirometry Through study completion, an average of 3 weeks
Secondary Quadriceps strength Maximal torque (Nm) achieved during isometric contraction Through study completion, an average of 3 weeks
Secondary Respiratory muscle function Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter) Through study completion, an average of 3 weeks
See also
  Status Clinical Trial Phase
Completed NCT03616093 - The Impact of Acute (2 h) and Short-term (4 Days) Nitrate Supplementation in the Form of Red Beet Root Juice on Intense Intermittent Exercise Performance. N/A
Completed NCT03294642 - Potato Ingestion and Time-trial Performance N/A
Completed NCT05831527 - An Exploratory Investigation of a Supplement to Promote Gut Health N/A
Not yet recruiting NCT03954665 - Ketone Supplementation and Exercise Performance N/A
Completed NCT04263246 - Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status N/A
Not yet recruiting NCT05428228 - Clinical Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults N/A
Recruiting NCT04004676 - Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise N/A
Completed NCT03565523 - The Effect of Dietary Nitrate Supplementation on Linear Running Sprint Performance, Agility and Vertical Jump Performance in a Rested and Fatigued State N/A
Recruiting NCT06066606 - U-LABA/ICS Effects on Exercise Performance, Vilanterol N/A
Recruiting NCT06077019 - Role of Lung Function for Exercise Capacity in Well-trained Individuals N/A
Completed NCT05559372 - Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes N/A
Completed NCT03525561 - Acetazolamide and Exercise Performance at Altitude Early Phase 1
Completed NCT03929575 - Effects of Herbal Supplements on Endurance Exercise Performance N/A
Completed NCT03977246 - Effect of Open-placebo Intervention on Cycling Performance N/A
Completed NCT03686982 - The Impact of Supplementation With Novel Prototype Nutrition Bar on Nitric Oxide Bioavailability and Measures of Athlete Performance N/A
Completed NCT06165523 - Kefir Versus Milk on Time-Trial Performance in Masters Athletes N/A
Completed NCT06390670 - The Effect of Colostrum Bovinum Supplementation in Endurance Athletes Phase 2/Phase 3
Completed NCT05586295 - Vitamin B Complex Improved Exercise Performance and Anti-fatigue N/A
Recruiting NCT06374641 - The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function N/A
Completed NCT05841407 - Beetroot Supplementation and High Intensity Exercise N/A