Performance, DetectionPhase 4NCT05352191
Beclomethasone in Healthy Athletes
A Phase 4 study testing Beclomethasone in people with Performance, Detection and Doping, run by Western Norway University of Applied Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance, Detection, Doping
- What is being tested?
- Beclomethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Maximal oxygen uptake >60 in male and >50 in female Signed informed consent.
- -
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Trine Stensrud, PhD contact
About this study
Official title: Beclomethasone in Healthy Athletes, Detection in Blood and Urine, and the Effect on Aerobic Performance
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.
Read the 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
- Being tested
- Beclomethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeclomethasoneDrug
inhaled 800ug
| Study group | Role | What they receive |
|---|---|---|
| Beclomethasone | Active comparator | 800 ug inhaled once aday for 8 days Receives: Drug: Beclomethasone |
| Placebo | Placebo comparator | one pill once aday for 8 days Receives: Drug: Beclomethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
20km cycling timetrial performance
ergometer
Measured: 3 weeks
Secondary outcomes (1)
Detection of beclometasone in urine and dried blood spots
blood and urine samples
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance, DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, The Norwegian Doping Control Laboratory
- Responsible party
- Principal investigator, Amund Riiser, Western Norway University of Applied Sciences
- Investigators
- Amund Riiser, PhD, Principal investigator, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352191
- Sponsor's protocol ID
- 123
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beclomethasone in Healthy Athletes, Detection in Blood and Urine, and the Effect on Aerobic Performance
- ClinicalTrials.gov ID
- NCT05352191
- Acronym / sponsor ID
- 123
- Conditions
- Performance, Detection, Doping
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences, The Norwegian Doping Control Laboratory
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone | Active comparator | Drug: Beclomethasone800 ug inhaled once aday for 8 days |
| Placebo | Placebo comparator | Drug: Beclomethasoneone pill once aday for 8 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Maximal oxygen uptake >60 in male and >50 in female Signed informed consent.
- -
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasoneinhaled 800ug | Drug | Beclomethasone, Placebo |
Primary outcome
20km cycling timetrial performance
Time frame: 3 weeks
ergometer
1 secondary outcome
Detection of beclometasone in urine and dried blood spots
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Performance, Detection
Active, not recruitingObservational study
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
Diquat Poisoning
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruitingObservational study
TOF-MRV Versus Post-Contrast 3D T1 MRI in Dural Venous Sinus Thrombosis
Cerebral Thrombosis, Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Stensrud, PhD contact
Amund Riiser, PhD principal investigator
Western Norway University of Applied Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beclomethasone in people with Performance, Detection and Doping, run by Western Norway University of Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amund Riiser, PhD (92688239, amund.riiser@hvl.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20km cycling timetrial performance (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.