Concentrations of Salmeterol 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:
NCT00914901
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 4, 2009
June 4, 2009
July 2009
March 2011   (final data collection date for primary outcome measure)
Serum and urine concentrations of salmeterol [ 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 Salmeterol in Blood and Urine
Blood and Urinary Concentrations of Inhaled Salmeterol in Asthmatic Subjects and Elite Athletes With Asthma.

The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.

The purpose of the study is to assess the serum and urine concentrations of salmeterol after inhalation of 100 microgram salmeterol in one dose.

Furthermore, to evaluate any difference in three groups: 10 healthy men, 10 male asthmatic subjects and 10 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 salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
  • Healthy
    10 healthy men
    Intervention: Drug: inhaled salmeterol
  • Asthmatics
    10 male asthmatic subjects
    Intervention: Drug: inhaled salmeterol
  • Elite athletes with asthma
    10 male elite athletes with asthma
    Intervention: Drug: inhaled salmeterol
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
March 2011
March 2011   (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/or allergy.
  • Allergy towards the study medicine.
  • Use of beta-2-agonist 10 days prior to study day.
Male
18 Years to 45 Years
Yes
Contact: Jimmi Elers, MD +45 35313208 jele0004@bbh.regionh.dk
Denmark
 
NCT00914901
SAL2009JE, EudraCT number 2009-012069-70
Yes
Jimmi Elers, Bispebjeg 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