Pharmacological Properties of Salmeterol

• Sponsor: University of Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02558088
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.

Hence, there is no hypothesis as such.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics in Healthy Young Men	Drug: Salmeterol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: salmeterol	Drug: Salmeterol

Outcome Measures

Primary Outcome Measures

1. Urine concentration of salmeterol [0-24 hours after administration of the study drug]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male

• 18-45 years

• Healthy

Exclusion Criteria:

• Chronic disease

• Smoking

• Habitual use of medicine

• Allergy towards salmeterol

• Unable to exercise on a bike ergometer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Hospital	Copenhagen	Select State	Denmark	2400

Sponsors and Collaborators

• University of Copenhagen

Investigators

• Principal Investigator: Vibeke Backer, Professor, Bispebjerg Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morten Nielsen, MSc., University of Copenhagen
• ClinicalTrials.gov Identifier: NCT02558088
• Other Study ID Numbers: WADA2013sal
• First Posted: Sep 23, 2015
• Last Update Posted: Jan 31, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Morten Nielsen, MSc., University of Copenhagen: salmeterol; pharmacokinetics; doping; beta2-agonists; long-acting beta2-agonists
• Additional relevant MeSH terms: Salmeterol Xinafoate

Study Results

No Results Posted as of Jan 31, 2017