Beclomethasone in Healthy Athletes

NCT ID: NCT05352191

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-01-01

Brief Summary

The present study aims to assess her urine concentration of beclomethasone during and after one week of use according to the World Antidoping agency's regulations. The study will assess utility of dried blood spots to detect use of beclomethasone and the effect approved use of beclomethasone has on endurance performance in healthy (non-asthmatic ) athletes.

Detailed Description

The study is a double-blinded, randomized, controlled parallel trial with participants visiting the laboratory on four separate occasions. The purpose of the first visit is to familiarize the participant with the exercise performance protocol as well as to assess a steady state oxygen consumption (VO2) at several submaximal work rates followed by a maximal VO2 (VO2max) test. For a given participant, trials on day two, three, and four will be identical conducted on the same time of day and separated by approximately one week. Beclomethasone or placebo will be delivered daily for one week from test three to test four. Urine and blood samples will be collected after testing on experimental test two and three and self-collected daily during the seven consecutive days of self-administration, and 3, 7 and 14 days after the participants stops taking medication.

Inhaled beclomethasone is approved by the World Anti-Doping Agency (WADA) for use by athletes in and out of competition. The dose used in our study is the highest single dose recommended by the Norwegian medical agency and half of the maximal daily dose recommended. Participants will inhale 800 μg beclometason or placebo using a standard inhaler (Easyhaler) used for asthma treatment. The inhaler delivers 200 μg of beclometasone with each actuation (i.e., 4 puffs/actuations gives 800 μg) with inhalation time being approximately ~1 min (12 breaths) and the manufacturer's user instructions will be followed.

The primary objective is endurance performance measured using a 20 km simulated time trial on a stationary bike. Performance will be measured time to task completion/mean power (watts) and b). Secondary objectives are the physiological response to exercise including: a) heart rate (bpm), b) minute ventilation (Lˑmin-1), c) oxygen uptake (Lˑmin-1), d) oxygen saturation (%), e) respiratory exchange ratio (RER), f) blood lactate and glucose concentration (mmolˑL-1), and f) lung function by spirometry (forced expiratory volume in 1 second, FEV1).

The first 30 participants eligible to the study will be recruited. They must be well trained cyclists and triathletes (VO2max in mLˑkg-1ˑmin-1 ≥60♂/≥50♀) aged between 18 and 35 years. Exclusion criteria include a doctor diagnosed asthma and/or the use of anti-asthmatic medications or glucocorticoids the last 12 months prior to participation. The participants must be free from chest infection for at least 4 weeks prior to assessment; and are not to be taking any medication and have no other health or medical contradictions to them taking part in the study as confirm by information provided on a physical activity readiness questionnaire.

Conditions

Performance, Detection; Doping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Beclomethasone

800 ug inhaled once aday for 8 days

Group Type: ACTIVE_COMPARATOR

Beclomethasone

Intervention Type: DRUG

inhaled 800ug

Placebo

one pill once aday for 8 days

Group Type: PLACEBO_COMPARATOR

Beclomethasone

Intervention Type: DRUG

inhaled 800ug

Interventions

Beclomethasone

inhaled 800ug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Healthy Maximal oxygen uptake >60 in male and >50 in female Signed informed consent.

-

Exclusion Criteria

Intention to compete within 3 days after last dose of medicament Asthma diagnosis Use of anti-asthmatic medication last 12 months Upper chest infection last 4 weeks Contraindication to maximal exercise Contraindication to glucocorticoids Pregnancy or possible pregnancy Failure to obtain written informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Norwegian School of Sport Sciences

UNKNOWN

Sponsor Role: collaborator

The Norwegian Doping Control Laboratory

UNKNOWN

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amund Riiser

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amund Riiser, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Norway University of Applied Sciences

Central Contacts

Amund Riiser, PhD

Role: CONTACT

amund.riiser@hvl.no

92688239

Trine Stensrud, PhD

Role: CONTACT

trine.stensrud@nih.no

Other Identifiers

123

Identifier Type: -

Identifier Source: org_study_id