SmokingNCT01521572
Effect of the Salbutamol on Mechanical Properties of Respiratory System
A study testing Salbutamol sulphate in people with Smoking and Airway Obstruction, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Airway Obstruction
- What is being tested?
- Salbutamol sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Sep 2012
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals, smokers and patients with chronic obstructive pulmonary disease.
Who cannot join
- healthy subjects: no history of smoking respiratory infection and disease respiratory
- smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory biomedical instrumentation - State University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 20550013
Gerusa M Costa, MSc
About this study
Official title: Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients
The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction.
Read the detailed description
Clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (FOT), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. After 20 minutes, the individual will be evaluated again following the same sequence.
- Conditions
- Smoking, Airway Obstruction
- Being tested
- Salbutamol sulphate
- Keywords
- chronic obstructive pulmonary disease,, bronchial reversibility,, bronchodilator,, respiratory impedance,, forced oscillation technique,, plethysmography,, spirometry, Diagnostic Techniques, Respiratory System
- Medical subject headings
- Smoking, Airway Obstruction, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol sulphateDrug
Also called Aerogold, GO/DRUGS/341/L, LOTE: YR1070
bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Experimental | Short-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease. Receives: Drug: Salbutamol sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function test
Evaluation of pulmonary mechanics before and after salbutamol (short-acting bronchodilator) in healthy individuals, smokers and chronic obstructive pulmonary disease in stages: mild, moderate, severe and very severe according to GOLD criteria.
Measured: two o'clock
Secondary outcomes (1)
Salbutamol
In the bronchodilator test will be used 400 micrograms of beta2-agonist short-acting. They will be asked to exhale slowly until they can no longer expel more air from the lungs. To place the inhaler with a spacer between the lips, pressing them well, but no bite. Shortly thereafter start to breathe through the mouth and will be released a jet of 100 micrograms of the bronchodilator. Then they will hold their breath for 10 seconds. 3 puffs are made with 1 minute interval between each application.
Measured: twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionJan 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Gerusa Maritimo da Costa, Rio de Janeiro State University
- Investigators
- Gerusa M Costa, MSc, Principal investigator, State University of Rio de JaneiroPedro L Melo, PhD, Study director, Laboratory biomedical instrumentation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521572
- Sponsor's protocol ID
- 2927/2011
- Other IDs
- CEP2927/2011HUPE
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Salbutamol on the Mechanical Properties of the Respiratory System of Healthy Individuals, Smokers and COPD Patients
- ClinicalTrials.gov ID
- NCT01521572
- Acronym / sponsor ID
- 2927/2011
- Conditions
- Smoking, Airway Obstruction
- Keywords
- chronic obstructive pulmonary disease,, bronchial reversibility,, bronchodilator,, respiratory impedance,, forced oscillation technique,, plethysmography,, spirometry, Diagnostic Techniques, Respiratory System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jun 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 30 Jan 2012 (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.
The aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and COPD with varying degrees of airway obstruction.
Detailed description
Clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (FOT), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. After 20 minutes, the individual will be evaluated again following the same sequence.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Experimental | Drug: Salbutamol sulphateShort-acting bronchodilator for use in humans released by the Ministry of Health, widely used worldwide for the treatment of chronic obstructive pulmonary disease. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals, smokers and patients with chronic obstructive pulmonary disease.
Key exclusion criteria (2 listed)
- healthy subjects: no history of smoking respiratory infection and disease respiratory
- smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.
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 |
|---|---|---|
| Salbutamol sulphateAlso: Aerogold, GO/DRUGS/341/L, LOTE: YR1070bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms. | Drug | Salbutamol |
Primary outcome
Respiratory function test
Time frame: two o'clock
Evaluation of pulmonary mechanics before and after salbutamol (short-acting bronchodilator) in healthy individuals, smokers and chronic obstructive pulmonary disease in stages: mild, moderate, severe and very severe according to GOLD criteria.
1 secondary outcome
Salbutamol
Time frame: twenty minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- http://www.ncbi.nlm.nih.gov/pubmed?term=gerusa%20maritimo%20da%20costaLink provided by the sponsor.
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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.
Gerusa M Costa, MSc principal investigator
State University of Rio de Janeiro
Pedro L Melo, PhD study director
Laboratory biomedical instrumentation
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 sulphate in people with Smoking and Airway Obstruction, run by Rio de Janeiro State University at 1 site in Brazil.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Feb 2012. 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 Brazil. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnaldo J Lopes, PhD (55+(21) 98536162, phel.lop@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory function test (time frame: two o'clock). 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 Feb 2012.