AsthmaPhase 4NCT00914797
Terbutaline Concentrations in Blood and Urine
A Phase 4 study testing inhaled and oral terbutaline in people with Asthma, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control. 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
- What is being tested?
- inhaled and oral terbutaline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Mar 2010
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physician-diagnosed asthma with positive reversibility or challenge test.
- Informed consent.
- Age between 18 - 45 years.
- Sex: male.
- Asthma classified as mild to moderate according to GINA guidelines.
- Used beta-2-agonist in minimum 12 months.
Who cannot join
- Smokers or ex-smokers with a smoking history of 10 pack years or more.
- Respiratory tract infections within the last 2 weeks prior to visit 1 and 2.
- Subjects with other chronic diseases than asthma and allergy.
- Allergy towards the study medicine.
- Use of beta-2-agonist 6 days prior to study day.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Respiratory Research Unit
København NV, DK-2400
Jimmi Elers, MD, +45 35313208, jele0004@bbh.regionh.dk
Jimmi Elers, MD
About this study
Official title: Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.
The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.
Read the detailed description
To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.
To investigate the above mentioned in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.
- Conditions
- Asthma
- Being tested
- inhaled and oral terbutaline
- Keywords
- Asthma, Doping, Beta agonist, Terbutaline, Pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled and oral terbutalineDrug
Also called Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076., Tablet Bricanyl Retard 5 mg, MA no. 10954.
Inhalation of 2 mg terbutaline as powder as a single dosage. Oral terbutaline 10 mg as a single dosage.
Inhaled: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076.
Oral: Tablet Bricanyl Retard 5 mg, MA no. 10954.
| Study group | Role | What they receive |
|---|---|---|
| asthmatics | Active comparator | 10 male asthmatic subjects Receives: Drug: inhaled and oral terbutaline |
| healthy | Active comparator | 10 male healthy volunteers Receives: Drug: inhaled and oral terbutaline |
| elite athletes with asthma | Active comparator | 10 elite athletes with asthma. Receives: Drug: inhaled and oral terbutaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Terbutaline concentrations in serum and urine
Measured: baseline, 4, 8, and 12 hours after medicine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Investigators
- Jimmi Elers, MD, Principal investigator, Bispebjerg Hospital, Respiratory Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914797
- Sponsor's protocol ID
- TER2009JE
- Status last verified
- Jun 2009
- First submitted
- 4 Jun 2009
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.
- ClinicalTrials.gov ID
- NCT00914797
- Acronym / sponsor ID
- TER2009JE
- Conditions
- Asthma
- Keywords
- Asthma, Doping, Beta agonist, Terbutaline, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Hormone Laboratory, Aker University Hospital, Oslo, Norway
- Study start
- Jul 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 5 Jun 2009 (estimated)
- 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 this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.
Detailed description
To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.
To investigate the above mentioned in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| asthmatics | Active comparator | Drug: inhaled and oral terbutaline10 male asthmatic subjects |
| healthy | Active comparator | Drug: inhaled and oral terbutaline10 male healthy volunteers |
| elite athletes with asthma | Active comparator | Drug: inhaled and oral terbutaline10 elite athletes with asthma. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physician-diagnosed asthma with positive reversibility or challenge test.
- Informed consent.
- Age between 18 - 45 years.
- Sex: male.
- Asthma classified as mild to moderate according to GINA guidelines.
Key exclusion criteria (5 listed)
- Smokers or ex-smokers with a smoking history of 10 pack years or more.
- Respiratory tract infections within the last 2 weeks prior to visit 1 and 2.
- Subjects with other chronic diseases than asthma and allergy.
- Allergy towards the study medicine.
- Use of beta-2-agonist 6 days prior to study day.
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 |
|---|---|---|
| inhaled and oral terbutalineAlso: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076., Tablet Bricanyl Retard 5 mg, MA no. 10954.Inhalation of 2 mg terbutaline as powder as a single dosage. Oral terbutaline 10 mg as a single dosage. Inhaled: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076. Oral: Tablet Bricanyl Retard 5 mg, MA no. 10954. | Drug | asthmatics, elite athletes with asthma, healthy |
Primary outcome
Terbutaline concentrations in serum and urine
Time frame: baseline, 4, 8, and 12 hours after medicine administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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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.
Jimmi Elers, MD principal investigator
Bispebjerg Hospital, Respiratory Research Unit
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 inhaled and oral terbutaline in people with 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: status not confirmed, as of the sponsor's last update on 5 Jun 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jimmi Elers½, MD (+45 35313208, jele0004@bbh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Terbutaline concentrations in serum and urine (time frame: baseline, 4, 8, and 12 hours after medicine administration). 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 5 Jun 2009.