The Influence of Exercise and Hydration to the Pharmacolo... | NCT05749523

Studies
The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men

NCT05749523

Sponsor

Vibeke Backer

Status

Withdrawn

Last Update Posted

Mar 1, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Healthy

Interventions

Exercise

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insuffient drug supply. Professor Ronald Dahl lefter his position as proffssor in Århus, and all his research were closed.

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Apr 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Jul 18, 2013

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 1, 2023Actual

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

Feb 27, 2023

Last Update Posted Date

Mar 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vibeke Backer, Professor, Dr. Med. Chief Physician, Bispebjerg HospitalSponsor-Investigator

Lead Sponsor

Vibeke BackerOTHER

Collaborators

Not provided

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

To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

Detailed Description

No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Other	Exercise vs. non-exercise	Behavioral: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	Exercise vs non-exercise	Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urine concentration of salbutamol and terbutalin	Urine concentration of salbutamol and terbutalin	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

men
aerobic capacity more than 50ml / min / kg
more than 5h training pr week

Exclusion Criteria:

smokers
allergy for the medicine
chronic diseases

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vibeke Backer, Professor	Dept of Respiratory Medicine, Bispebjerg University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Respiratory Medicine, L, Bispebjerg Hospital,		Copenhagen	NV	2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity
D003681	Dehydration

Ancestor Terms

ID	Term
D001519	Behavior
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided