Exercise PerformanceNCT06105671
U-LABA/ICS Effects on Exercise Performance, Formoterol
A study testing Symbicort, Formoterol and Mannitol in people with Exercise Performance, run by Morten Hostrup, PhD at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- What is being tested?
- Symbicort, Formoterol and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jan 2024to 4 Jul 2024
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Who cannot join
- Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- ECG abnormality
- FEV1/FVC ratio < 0,7 determined with spirometry
- Chronic illness determined to be a potential risk for participant during the study
- In chronic treatments with medication that may interfere with study results
- Pregnancy
- Smoker
- Blood donation during the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol
The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.
- Conditions
- Exercise Performance
- Being tested
- Symbicort, Formoterol, Placebo, Mannitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbicortDrug
Participants are administered 54 μg Formoterol and 1920 μg Budesonide
FormoterolDrug
Participants are administered 54 μg Formoterol from an inhaler device
FormoterolDrug
Participants are administered 120 μg Formoterol in a capsule, which is taken orally
PlaceboDrug
Participants are administered placebo
MannitolDrug
Participants are administered 600 mg Bronchitol
| Study group | Role | What they receive |
|---|---|---|
| Symbicort - usual care | Experimental | Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. Receives: Drug: Symbicort |
| Formoterol - inhalation | Experimental | Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. Receives: Drug: Formoterol |
| Formoterol - oral | Experimental | Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device. Receives: Drug: Formoterol |
| Placebo | Placebo comparator | Participants are administered placebo from an inhaler device testing and a placebo capsule. Receives: Drug: Placebo |
| Mannitol-test | Experimental | Participants are administered Bronchitol from an inhaler device testing. Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power output during time trial
Mean power output measured in Watts during a time trial on a bike ergometer
Measured: Through study completion, an average on 4 weeks
Secondary outcomes (1)
Power output during sprint testing
Power output measured in Watts during a sprint on a bike ergometer
Measured: Through study completion, an average on 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 Jan 2024
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morten Hostrup, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Morten Hostrup, PhD, University of Copenhagen
- Investigators
- Morten Hostrup, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105671
- Sponsor's protocol ID
- FOR
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol
- ClinicalTrials.gov ID
- NCT06105671
- Acronym / sponsor ID
- FOR
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Morten Hostrup, PhDUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 30 Oct 2023 (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 purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Symbicort - usual care | Experimental | Drug: SymbicortParticipants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. |
| Formoterol - inhalation | Experimental | Drug: FormoterolParticipants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. |
| Formoterol - oral | Experimental | Drug: FormoterolParticipants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants are administered placebo from an inhaler device testing and a placebo capsule. |
| Mannitol-test | Experimental | Drug: MannitolParticipants are administered Bronchitol from an inhaler device testing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-45
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Key exclusion criteria (8 listed)
- Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- ECG abnormality
- FEV1/FVC ratio < 0,7 determined with spirometry
- Chronic illness determined to be a potential risk for participant during the study
- In chronic treatments with medication that may interfere with study results
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 |
|---|---|---|
| SymbicortParticipants are administered 54 μg Formoterol and 1920 μg Budesonide | Drug | Symbicort - usual care |
| FormoterolParticipants are administered 54 μg Formoterol from an inhaler device | Drug | Formoterol - inhalation |
| FormoterolParticipants are administered 120 μg Formoterol in a capsule, which is taken orally | Drug | Formoterol - oral |
| PlaceboParticipants are administered placebo | Drug | Placebo |
| MannitolParticipants are administered 600 mg Bronchitol | Drug | Mannitol-test |
Primary outcome
Power output during time trial
Time frame: Through study completion, an average on 4 weeks
Mean power output measured in Watts during a time trial on a bike ergometer
1 secondary outcome
Power output during sprint testing
Time frame: Through study completion, an average on 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Morten Hostrup, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbicort, Formoterol and Mannitol in people with Exercise Performance, run by Morten Hostrup, PhD at 1 site in Denmark.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power output during time trial (time frame: Through study completion, an average on 4 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 13 Aug 2024.