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Terbutaline Concentrations in Blood and Urine

Information source: Bispebjerg Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: inhaled and oral terbutaline (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 ElersĀ½, MD, Phone: +45 35313208, Email: jele0004@bbh.regionh.dk

Summary

The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.

Clinical Details

Official title: Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.

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

Primary outcome: Terbutaline concentrations in serum and urine

Detailed description: To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline. To investigate the above mentioned in 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 visit 1 and 2.

- Subjects with other chronic diseases than asthma and allergy.

- Allergy towards the study medicine.

- Use of beta-2-agonist 6 days prior to study day.

Locations and Contacts

Jimmi ElersĀ½, MD, Phone: +45 35313208, Email: jele0004@bbh.regionh.dk

Bispebjerg Hospital, Respiratory Research Unit, Kobenhavn NV DK-2400, Denmark; Not yet recruiting
Jimmi Elers, MD, Phone: +45 35313208, Email: jele0004@bbh.regionh.dk
Jimmi Elers, MD, Principal Investigator
Additional Information

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

Page last updated: August 23, 2015

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