NCT05352191

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

April 22, 2022

Last Update Submit

April 22, 2022

Conditions

Performance, DetectionDoping

Outcome Measures

Primary Outcomes (1)

  • 20km cycling timetrial performance

    ergometer

    3 weeks

Secondary Outcomes (1)

  • Detection of beclometasone in urine and dried blood spots

    3 weeks

Study Arms (2)

Beclomethasone

ACTIVE COMPARATOR

800 ug inhaled once aday for 8 days

Drug: Beclomethasone

Placebo

PLACEBO COMPARATOR

one pill once aday for 8 days

Drug: Beclomethasone

Interventions

BeclomethasoneDRUG

inhaled 800ug

BeclomethasonePlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Beclomethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Amund Riiser, PhD

    Western Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amund Riiser, PhD

CONTACT

92688239amund.riiser@hvl.no

Trine Stensrud, PhD

CONTACT

trine.stensrud@nih.no

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
placebo
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share