Concentrations of Formoterol in Blood and Urine

Tracking Information
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; (submitted: June 4, 2009)	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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
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.
Study Arms	Healthty 10 healthy men Intervention: Drug: inhaled formoterol; Asthmatics 10 male asthmatic subjects Intervention: Drug: inhaled formoterol; Elite asthmatics 10 male elite athletes with asthma Intervention: Drug: inhaled formoterol
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: June 4, 2009)	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: 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. Exclusion Criteria: Smokers or ex-smokers with a smoking history of 10 pack years or more.; Respiratory tract infections within the last 2 weeks prior to study day.; Subjects with other chronic diseases than asthma and allergy.; Allergy towards the study medicine.; Use of beta-2-agonist 10 days prior to study day.
Sex/Gender	Sexes Eligible for Study: Male
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
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	Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
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