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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
  Purpose

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


Condition Intervention Phase
Asthma
 Drug: inhaled formoterol
 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 Formoterol 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 formoterol [ 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: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthty
10 healthy men
 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.
Asthmatics
10 male asthmatic subjects
 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.
Elite asthmatics
10 male elite athletes with 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.

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.

  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 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: NCT00914654

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

Locations
Denmark
Bispebjerg Hospital, Respiratory Research Unit
Kobenhavn NV, Denmark, DK-2400
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, Bispebjerg Hospital, Respiratory Research Unit
ClinicalTrials.gov Identifier: NCT00914654     History of Changes
Other Study ID Numbers: FOR2009JE, EudraCT number 2009-012039-14
Study First Received: June 4, 2009
Last Updated: June 4, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Asthma
Doping
Formoterol
Urinary concentrations
Beta-agonists

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
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 June 17, 2013