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Concentrations of Formoterol in Blood and Urine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Bispebjerg Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00914654
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 4, 2009
June 4, 2009
July 2009
December 2010   (final data collection date for primary outcome measure)
Serum and urine concentrations of formoterol [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Concentrations of Formoterol in Blood and Urine
Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma
The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Asthma
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years   (Adult)
Yes
Contact: Jimmi Elers, MD +45 35313208 jele0004@bbh.regionh.dk
Denmark
 
NCT00914654
FOR2009JE, EudraCT number 2009-012039-14
Yes
Not Provided
Not Provided
Jimmi Elers, Bispebjerg Hospital, Respiratory Research Unit
Bispebjerg Hospital
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
Bispebjerg Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP