NCT01415596

Brief Summary

Many athletes use beta2-agonists as treatment of airway hyperresponsiveness during exercise. High dose beta2-agonists may have an ergogenic effect on exercise performance. We hypotheis that the beta2-agonist, salbutamol, taken in high doses can improve muscle power and recovery during exercise in well-trained athletes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 12, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

August 11, 2011

Last Update Submit

August 11, 2011

Conditions

Ergogenic Effects of Salbutamol in Healthy Males

Outcome Measures

Primary Outcomes (1)

  • Muscle power

Secondary Outcomes (1)

  • Muscle recovery

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Salbutamol

ACTIVE COMPARATOR
Drug: salbutamol

Interventions

salbutamolDRUG
Salbutamol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males
  • age 18-45
  • training frequency \> 10 hrs/wk
  • informed consent

You may not qualify if:

  • smoker or former smoker
  • chronic diseases, as well as asthma
  • allergy to the study drugs
  • intake of any form of medicin or inhibited drugs during the study
  • use of beta2-agonist 14 days before the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen Northwest, DK-2400, Denmark

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2011

First Posted

August 12, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2013

Last Updated

August 12, 2011

Record last verified: 2011-03

Locations

DK(1)