HealthyPhase 4NCT05749523
The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men
A Phase 4 study testing Exercise in people with Healthy, run by Vibeke Backer at 1 site in Denmark.
Trial summary
To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Sep 2014
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- men
- aerobic capacity more than 50ml / min / kg
- more than 5h training pr week
Who cannot join
- smokers
- allergy for the medicine
- chronic diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Respiratory Medicine, L, Bispebjerg Hospital,
Copenhagen, NV, 2400
About this study
To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.
Read the detailed description
No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.
- Conditions
- Healthy
- Being tested
- Exercise
- Keywords
- exercise, dehydration, Salbutamol, Terbutalin
- Medical subject headings
- Motor Activity, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise vs non-exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Exercise vs. non-exercise Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of salbutamol and terbutalin
Urine concentration of salbutamol and terbutalin
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study startNov 2013
- Primary completionApr 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: Insuffient drug supply. Professor Ronald Dahl lefter his position as proffssor in Århus, and all his research were closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibeke Backer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, Professor, Principal investigator, Dept of Respiratory Medicine, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749523
- Sponsor's protocol ID
- 2013-000483-29
- Status last verified
- Feb 2023
- First submitted
- 18 Jul 2013
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men
- ClinicalTrials.gov ID
- NCT05749523
- Acronym / sponsor ID
- 2013-000483-29
- Conditions
- Healthy
- Keywords
- exercise, dehydration, Salbutamol, Terbutalin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insuffient drug supply. Professor Ronald Dahl lefter his position as proffssor in Århus, and all his research were closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vibeke BackerUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 1 Mar 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.
To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.
Detailed description
No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Behavioral: ExerciseExercise vs. non-exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- men
- aerobic capacity more than 50ml / min / kg
- more than 5h training pr week
Key exclusion criteria (3 listed)
- smokers
- allergy for the medicine
- chronic diseases
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 |
|---|---|---|
| ExerciseExercise vs non-exercise | Behavioural | Exercise |
Primary outcome
Urine concentration of salbutamol and terbutalin
Time frame: 7 days
Urine concentration of salbutamol and terbutalin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
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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.
Vibeke Backer, Professor principal investigator
Dept of Respiratory Medicine, Bispebjerg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise in people with Healthy, run by Vibeke Backer 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 3 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: withdrawn, as of the sponsor's last update on 1 Mar 2023. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Urine concentration of salbutamol and terbutalin (time frame: 7 days). 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 1 Mar 2023.