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Concentrations of Formoterol in Blood and Urine

Information source: Bispebjerg Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: inhaled formoterol (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Bispebjerg Hospital

Official(s) and/or principal investigator(s):
Jimmi Elers, MD, Principal Investigator, Affiliation: Bispebjerg Hospital, Respiratory Research Unit

Overall contact:
Jimmi Elers, MD, Phone: +45 35313208, Email: jele0004@bbh.regionh.dk

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Serum and urine concentrations of 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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

Locations and Contacts

Jimmi Elers, MD, Phone: +45 35313208, Email: jele0004@bbh.regionh.dk

Bispebjerg Hospital, Respiratory Research Unit, Kobenhavn NV DK-2400, Denmark
Additional Information

Starting date: July 2009
Last updated: June 4, 2009

Page last updated: February 07, 2013

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