Concentrations of Formoterol 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

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

Tracking Information

First Received Date ^ICMJE

June 4, 2009

Last Updated Date

June 4, 2009

Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Serum and urine concentrations of formoterol [ Time Frame: baseline, 4, 8, and 12 hours after medicine administration ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Concentrations of Formoterol in Blood and Urine

Official Title ^ICMJE

Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma

Brief Summary

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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.

Study Arms

Healthty
10 healthy men

Intervention: Drug: inhaled formoterol
Asthmatics
10 male asthmatic subjects

Intervention: Drug: inhaled formoterol
Elite asthmatics
10 male elite athletes with asthma

Intervention: Drug: inhaled formoterol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years to 45 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00914654

Other Study ID Numbers ^ICMJE

FOR2009JE
EudraCT number 2009-012039-14

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Jimmi Elers, Bispebjerg Hospital, Respiratory Research Unit

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Hormone Laboratory, Aker University Hospital, Oslo, Norway

Investigators ^ICMJE

Principal Investigator:

Jimmi Elers, MD

Bispebjerg Hospital, Respiratory Research Unit

PRS Account

Bispebjerg Hospital

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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