Concentrations of Formoterol in Blood and Urine
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ClinicalTrials.gov Identifier: NCT00914654 |
Recruitment Status
: Unknown
Verified June 2009 by Bispebjerg Hospital.
Recruitment status was: Not yet recruiting
First Posted
: June 5, 2009
Last Update Posted
: June 5, 2009
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Sponsor:
Bispebjerg Hospital
Collaborator:
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Information provided by:
Bispebjerg Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | June 4, 2009 | |||
First Posted Date ICMJE | June 5, 2009 | |||
Last Update Posted Date | June 5, 2009 | |||
Study Start Date ICMJE | July 2009 | |||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Serum and urine concentrations of formoterol [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Concentrations of Formoterol in Blood and Urine | |||
Official Title ICMJE | Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma | |||
Brief Summary | The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol. | |||
Detailed Description | The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose. Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) |
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Condition ICMJE | Asthma | |||
Intervention ICMJE | Drug: inhaled formoterol
Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.
Other Name: Oxis Turbohaler 9 microg/dose, MA no. 30072. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | December 2010 | |||
Estimated Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Denmark | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00914654 | |||
Other Study ID Numbers ICMJE | FOR2009JE EudraCT number 2009-012039-14 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Jimmi Elers, Bispebjerg Hospital, Respiratory Research Unit | |||
Study Sponsor ICMJE | Bispebjerg Hospital | |||
Collaborators ICMJE | Hormone Laboratory, Aker University Hospital, Oslo, Norway | |||
Investigators ICMJE |
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PRS Account | Bispebjerg Hospital | |||
Verification Date | June 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |