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
|
