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Concentrations of Salmeterol in Blood and Urine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Bispebjerg Hospital.
Recruitment status was:  Not yet recruiting
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Information provided by:
Bispebjerg Hospital Identifier:
First received: June 4, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
The purpose of the study is to assess the blood and urine concentrations of inhaled salmeterol.

Condition Intervention Phase
Drug: inhaled salmeterol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Blood and Urinary Concentrations of Inhaled Salmeterol in Asthmatic Subjects and Elite Athletes With Asthma.

Resource links provided by NLM:

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Serum and urine concentrations of salmeterol [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
10 healthy men
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
10 male asthmatic subjects
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
Elite athletes with asthma
10 male elite athletes with asthma
Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00914901

Bispebjerg Hospital, Respiratory Research Unit
Kobenhavn NV, Denmark, DK-2400
Sponsors and Collaborators
Bispebjerg Hospital
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
  More Information

Responsible Party: Jimmi Elers, Bispebjeg Hospital, Respiratory Research Unit Identifier: NCT00914901     History of Changes
Other Study ID Numbers: SAL2009JE  EudraCT number 2009-012069-70 
Study First Received: June 4, 2009
Last Updated: June 4, 2009

Keywords provided by Bispebjerg Hospital:
Urine concentrations

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on February 20, 2017