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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
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: inhaled salmeterol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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
Healthy
10 healthy men
 Drug: inhaled salmeterol
Inhalation of 100 micrograms salmeterol in one dose.
Asthmatics
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914901

Contacts
Contact: Jimmi Elers, MD +45 35313208 jele0004@bbh.regionh.dk

Locations
Denmark
Bispebjerg Hospital, Respiratory Research Unit Not yet recruiting
Kobenhavn NV, Denmark, DK-2400
Contact: Jimmi Elers, MD     +45 35313208     jele0004@bbh.regionh.dk    
Principal Investigator: Jimmi Elers, MD            
Sponsors and Collaborators
Bispebjerg Hospital
Hormone Laboratory, Aker University Hospital, Oslo, Norway
Investigators
Principal Investigator: Jimmi Elers, MD Bispebjerg Hospital, Respiratory Research Unit
  More Information

No publications provided

Responsible Party: Jimmi Elers, Bispebjeg Hospital, Respiratory Research Unit
ClinicalTrials.gov 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
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Asthma
Doping
Salmeterol
Beta-agonist
Urine concentrations

Additional relevant MeSH terms:
Bronchial Diseases
Asthma
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013