AsthmaProcatNCT05749536
Pharmacokinetics of Procaterol in Elite Athletes
An observational study of Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2011to Oct 2013
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Asthmatic and healthy volunteers
Who may be able to join
- Doctor diagnosed asthma for the asthmatic group
- GINA 1-3 for the asthmatic group
- Use of beta2-agonist for at least 12 months for the asthmatic group
- age 18-45
- males
- informed consent
Who cannot join
- smoker or former smoker
- airway infection to weeks prior to the study or during the study
- other chronic diseaes than asthma and allergy
- Use of beta2-agonist 6 days prior to the study
- Allergy to the study medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Procaterol in Elite Athletes - a PK Study
The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.
Read the detailed description
Doping study
- Conditions
- Asthma
- Keywords
- elite athletes
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | With positive asthma test | |
| Healthy | With no signs of asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
urine concentration of drug 0-24 h
In healthy subjects to investigate drug farmakokenetic
Measured: 7 days
serum concentration of drug 0-24 h
In healthy subjects to investigate drug farmakokenetic
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 startAug 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, MD, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749536
- Sponsor's protocol ID
- Procaterol
- Acronym
- Procat
- Status last verified
- Feb 2023
- First submitted
- 5 Nov 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
- Procaterol in Elite Athletes - a PK Study
- ClinicalTrials.gov ID
- NCT05749536
- Acronym / sponsor ID
- Procat / Procaterol
- Conditions
- Asthma
- Keywords
- elite athletes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- 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.
The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.
Detailed description
Doping study
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –With positive asthma test |
| Healthy | – | –With no signs of asthma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Asthmatic and healthy volunteers
Key inclusion criteria (6 listed)
- Doctor diagnosed asthma for the asthmatic group
- GINA 1-3 for the asthmatic group
- Use of beta2-agonist for at least 12 months for the asthmatic group
- age 18-45
- males
Key exclusion criteria (5 listed)
- smoker or former smoker
- airway infection to weeks prior to the study or during the study
- other chronic diseaes than asthma and allergy
- Use of beta2-agonist 6 days prior to the study
- Allergy to the study medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
urine concentration of drug 0-24 h
Time frame: 7 days
In healthy subjects to investigate drug farmakokenetic
serum concentration of drug 0-24 h
Time frame: 7 days
In healthy subjects to investigate drug farmakokenetic
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 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, MD principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Bispebjerg Hospital 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 6 inclusion and 5 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 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.
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?
urine concentration of drug 0-24 h (time frame: 7 days). The study lists 2 primary outcomes in all. 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.