Concentrations of Formoterol in Blood and Urine

• Sponsor: Bispebjerg Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00914654
• Collaborator: Hormone Laboratory, Aker University Hospital, Oslo, Norway (Other)
• Enrollment: 30
• Location: 1
• Arms: 3
• Duration (Months): 17
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: inhaled formoterol	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma
• Study Start Date: Jul 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthty 10 healthy men	Drug: inhaled formoterol; Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.; Other Names: Oxis Turbohaler 9 microg/dose, MA no. 30072.
Other: 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 Names: Oxis Turbohaler 9 microg/dose, MA no. 30072.
Other: 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 Names: Oxis Turbohaler 9 microg/dose, MA no. 30072.

Outcome Measures

Primary Outcome Measures

1. Serum and urine concentrations of formoterol [baseline, 4, 8, and 12 hours after medicine administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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 allergy.

• Allergy towards the study medicine.

• Use of beta-2-agonist 10 days prior to study day.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00914654
• Other Study ID Numbers: FOR2009JE; EudraCT number 2009-012039-14
• First Posted: Jun 5, 2009
• Last Update Posted: Jun 5, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Asthma; Doping; Formoterol; Urinary concentrations; Beta-agonists
• Additional relevant MeSH terms: Asthma; Formoterol Fumarate

Study Results

No Results Posted as of Jun 5, 2009