Can Anti-asthmatic Medication Improve Sprint Performance in Healthy Endurance Athletes?

NCT04402658 | Withdrawn

• 1 other identifier: NorwegianSSS2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of asthma among athletes is higher than in the normal population and endurance athletes are especially at increased risk. The gold standard for asthma treatment is inhaled glucocorticoids with inhaled beta2 agonists before exercise and as a symptom relief. However, the use of beta2 agonists in sports is debated because of potential performance-enhancing effects and its use is regulated by the World Anti-Doping Agency (WADA). The potential performance-enhancing effect of beta2 agonists on endurance performance and sprint performance has each been investigated in several studies as it has been suspected that non-asthmatic athletes use beta2 agonists for the purpose of improving performance. In conclusion, beta2 agonists do not improve endurance athletic performance in the doses and methods of use permitted by WADA. When it comes to anaerobic performance, the evidence is currently non-conclusive as studies report conflicting effects. It is therefore conceivable that beta2 agonists can improve the ability to sprint and increase power output during short periods of high energy expenditure during an endurance competition. By testing such anaerobic skills during endurance work in athletes, this study will provide valuable knowledge about whether this drug may affect sports performance and will be of interest to WADA and anyone else interested in fair play in sports. The purpose of the project is to investigate whether the use of a WADA approved dose of salbutamol (albuterol/Ventoline) has a performance-enhancing effect on sprint performance during and after endurance work on an ergometer bike. Well-trained cyclists who do not have asthma will perform two identical cycling protocols on two different days. The study is designed as a double-blind cross-over study with placebo. Participants will perform multiple 30-second sprints during a standard submaximal effort to investigate the effect of salbutamol on the maximum and average power of these sprints.

Conditions

Sports Drug Abuse

Keywords

Anaerobic performance; Athletes; Doping; Asthma; Endurance sports

Outcome Measures

Primary Outcomes (3)

• Anaerobic performance

  Measures as mean power (Watts) from the 30-second Wingate tests carried out on an ergometer cycle.

  Differences between experimental trial and placebo trial at 15 minutes

• Anaerobic performance

  Measures as mean power (Watts) from the 30-second Wingate tests carried out on an ergometer cycle.

  Differences between experimental trial and placebo trial at 30 minutes

• Sprint performance

  Mean power (Watts) during an all-out sprint on an ergometer cycle.

  Differences between experimental trial and placebo trial at 60 minutes

Secondary Outcomes (6)

• Forced expiratory volume in 1 second (FEV1)

  Change from baseline FEV1 at 15 minutes

• Forced expiratory volume in 1 second (FEV1)

  Change from baseline FEV1 at 30 minutes

• Forced expiratory volume in 1 second (FEV1)

  Difference from placebo trial at 30 minutes

• Heart rate (btp)

  Change from baseline heart rate at 15 minutes

• Heart rate (btp)

  Change from baseline heart rate at 30 minutes

Study Arms (1)

Physical performance test

EXPERIMENTAL

After performing measurements of lung function by spirometry, participants will inhale either salbutamol or placebo. After 15 minutes of rest, a second spirometry will be performed before the participants warm-up by 10 minutes cycling. The exercise protocol will consist of 60 minutes of cycling at 70% of maximal oxygen consumption (VO2max) on the cycle ergometer followed by an all-out sprint. Several times during the exercise test, 30-second Wingate tests will be conducted. Participants will be blinded to feedback such as power (W), distance covered, and heart rate. Strong verbal encouragement will be given to each participant for them to perform their best. Measurements of lung function (spirometry), heart rate, arterial oxygen saturation and Borg ratings of perceived exercising will be recorded throughout the trials, as well as capillary blood sampled for analysis of \[La-\] and \[Glucose\].

Drug: Inhaled salbutamol

Interventions

Inhaled salbutamol DRUG

Participants will inhale 800 μg salbutamol (or placebo) using a standard metered dose inhaler used for asthma treatment, and a standard spacer device will be used to allow optimal delivery of the drug to the lung. The inhaler delivers 100 μg of salbutamol with each actuation (i.e., 8 puffs/actuations gives 800 μg) with inhalation time being approximately \~2 min (10 breaths) and the manufacturer's user instructions will be followed. Although complete uptake of salbutamol cannot be concluded as any salbutamol left in the spacer, mouth or remaining in the lung will be not measured. This dose of Salbutamol is chosen because it is the highest dose permitted by the World Anti Doping Agency (WADA).

Physical performance test

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• well trained cyclists and triathletes (VO2max in mLˑkg-1ˑmin-1 ≥ 65 male/55 female) who are actively engaged in endurance cycling training at least 4 times per week.

You may not qualify if:

• a doctor diagnosed asthma and/or the use of anti-asthmatic medications the last 12 months prior to participation.

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Julie S Stang, PhD

  Norwegian School of Sport Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Both participants and key study personnel will be blinded for the intervention as an external person will provide the participant with sequentially numbered drug containers of identical appearance, for salbutamol and placebo, respectively.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The present study has a double-blinded and randomized cross-over design with participants visiting the laboratory on three separate occasions. The purpose of the first visit is to familiarize the participant with the equipment and the exercise performance protocol as well as to assess physiologic exercise data that will be used to determine the power output of the endurance exercise protocol on visits two and three. For a given participant, trials on day two and three will be conducted in randomized order, on the same time of day, and separated by more than 72 hours to ensure complete wash-out of salbutamol, and less than three weeks. The randomization will be performed using a computer random number generator.

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 27, 2020
• Study Start: August 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: December 20, 2023
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share