Adrenergic Beta-2 Agonist EffectBETACTIVNCT02925130
Beta2-mimetic and Central Nervous System
A study testing Salbutamol in people with Adrenergic Beta-2 Agonist Effect and Albuterol Effect, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adrenergic Beta-2 Agonist Effect, Albuterol Effect
- What is being tested?
- Salbutamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without respiratory and cordiovascular diseases
- Male
- Age between 18 and 35
- Trained subjects (>6 hours of physical activity per week)
- Non- or ex-smoker (smoking cessation since at least 1 year)
Who cannot join
- Respiratory, cardiovascular and metabolic diseases
- Neuromuscular diseases
- thyrotoxicosis, or diabetes treated with insulin
- alcoholism
- MRI contraindication
- TMS contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation
Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.
Read the detailed description
The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation and cerebral activation will be measured during motor tasks performed until exhaustion after acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.
- Conditions
- Adrenergic Beta-2 Agonist Effect, Albuterol Effect
- Being tested
- Salbutamol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called Albuterol
Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
PlaceboDrug
Also called Albuterol
Acute oral intake of a placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Salbutamol | Experimental | Acute inhalation of 800 microgram Salbutamol Receives: Drug: Salbutamol |
| Oral Salbutamol | Experimental | Acute oral intake of 4 mg Salbutamol Receives: Drug: Salbutamol |
| Placebo | Placebo comparator | Acute oral intake of a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary activation
Measurement performed by using transcranial magnetic stimulation, superimposed on submaximal and maximal quadricep contractions
Measured: Measured immediatly after treatment intake (within 1 h)
Secondary outcomes (2)
Cortical activation
Measurement performed by using magnetic resonance imaging and the intensity of the BOLD signal in response to a motor task.
Measured: Measured immediatly after treatment intake (within 1 h)
Exercise endurance
Time to exhaustion during the exercise muscle test.
Measured: Measured immediatly after treatment intake (within 1 h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenergic Beta-2 Agonist EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Guinot, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925130
- Sponsor's protocol ID
- 38RC14339
- Acronym
- BETACTIV
- Status last verified
- Mar 2017
- First submitted
- 3 Oct 2016
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation
- ClinicalTrials.gov ID
- NCT02925130
- Acronym / sponsor ID
- BETACTIV / 38RC14339
- Conditions
- Adrenergic Beta-2 Agonist Effect, Albuterol Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.
Detailed description
The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation and cerebral activation will be measured during motor tasks performed until exhaustion after acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inhaled Salbutamol | Experimental | Drug: SalbutamolAcute inhalation of 800 microgram Salbutamol |
| Oral Salbutamol | Experimental | Drug: SalbutamolAcute oral intake of 4 mg Salbutamol |
| Placebo | Placebo comparator | Drug: PlaceboAcute oral intake of a placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects without respiratory and cordiovascular diseases
- Male
- Age between 18 and 35
- Trained subjects (>6 hours of physical activity per week)
- Non- or ex-smoker (smoking cessation since at least 1 year)
Key exclusion criteria (6 listed)
- Respiratory, cardiovascular and metabolic diseases
- Neuromuscular diseases
- thyrotoxicosis, or diabetes treated with insulin
- alcoholism
- MRI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolAlso: AlbuterolAcute intake of Albuterol, a beta2-mimetic, either inhaled or oral. | Drug | Inhaled Salbutamol, Oral Salbutamol |
| PlaceboAlso: AlbuterolAcute oral intake of a placebo drug | Drug | Placebo |
Primary outcome
Maximal voluntary activation
Time frame: Measured immediatly after treatment intake (within 1 h)
Measurement performed by using transcranial magnetic stimulation, superimposed on submaximal and maximal quadricep contractions
2 secondary outcomes
Cortical activation
Time frame: Measured immediatly after treatment intake (within 1 h)
Exercise endurance
Time frame: Measured immediatly after treatment intake (within 1 h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Guinot, MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol in people with Adrenergic Beta-2 Agonist Effect and Albuterol Effect, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal voluntary activation (time frame: Measured immediatly after treatment intake (within 1 h)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.