Terbutaline Concentrations in Blood and Urine | NCT00914797

Studies
Terbutaline Concentrations in Blood and Urine

NCT00914797

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Jun 5, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Asthma

Interventions

inhaled and oral terbutaline

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Jun 4, 2009

First Submission Date that Met QC Criteria

Jun 4, 2009

First Posted Date

Jun 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2009

Last Update Posted Date

Jun 5, 2009Estimated

Name	Class
Hormone Laboratory, Aker University Hospital, Oslo, Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
asthmatics	Active Comparator	10 male asthmatic subjects	Drug: inhaled and oral terbutaline
healthy	Active Comparator	10 male healthy volunteers	Drug: inhaled and oral terbutaline
elite athletes with asthma	Active Comparator	10 elite athletes with asthma.	Drug: inhaled and oral terbutaline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inhaled and oral terbutaline	Drug	Inhalation of 2 mg terbutaline as powder as a single dosage. Oral terbutaline 10 mg as a single dosage. Inhaled: Bricanyl Turbohaler 0.5 mg/dose, MA no. 41076. Oral: Tablet Bricanyl Retard 5 mg, MA no. 10954.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Terbutaline concentrations in serum and urine		baseline, 4, 8, and 12 hours after medicine administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jimmi Elers½, MD	Contact	+45 35313208		jele0004@bbh.regionh.dk

Overall Officials

Name	Affiliation	Role
Jimmi Elers, MD	Bispebjerg Hospital, Respiratory Research Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital, Respiratory Research Unit		København NV		DK-2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001239	Inhalation
D013726	Terbutaline

Ancestor Terms

ID	Term
D015656	Respiratory Mechanics
D012119	Respiration
D012143	Respiratory Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided