Smokingsmoker3NCT02141633
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
A study testing echocardiogram plus albuterol, airway blood flow plus albuterol and Fluticasone propionate in people with Smoking, run by University of Miami at 1 site in United States.
Trial summary
The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- echocardiogram plus albuterol, airway blood flow plus albuterol and Fluticasone propionate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.
Who cannot join
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
- Cardiovascular disease and/or use of cardiovascular medications
- Subjects with known beta-adrenergic agonist intolerance
- A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
- Acute respiratory infection within four weeks prior to the study
- Use of any airway medication
- Abnormal pulmonary function
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami School of Medicine
Miami, Florida, 33136
About this study
The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Read the detailed description
With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).
- Conditions
- Smoking
- Being tested
- echocardiogram plus albuterol, airway blood flow plus albuterol, Fluticasone propionate, placebo
- Keywords
- smokers, airway blood flow, fluticasone, echocardiogram
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiogram plus albuterolProcedure or surgery
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
airway blood flow plus albuterolProcedure or surgery
Also called Qaw
participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Fluticasone propionateDrug
participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)
placeboDrug
participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
| Study group | Role | What they receive |
|---|---|---|
| smokers | Experimental | participants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation Receives: Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol; Drug: Fluticasone propionate; Drug: placebo |
| non-smokers | Experimental | healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation Receives: Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Blood Flow
compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers
Measured: before and 15 minutes after albuterol inhalation
Secondary outcomes (1)
Echocardiogram
to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers
Measured: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startApr 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Wanner, University of Miami
- Investigators
- Adam Wanner, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141633
- Sponsor's protocol ID
- 20120896
- Acronym
- smoker3
- Status last verified
- Oct 2016
- First submitted
- 25 Mar 2014
- Last updated
- 16 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
- ClinicalTrials.gov ID
- NCT02141633
- Acronym / sponsor ID
- smoker3 / 20120896
- Conditions
- Smoking
- Keywords
- smokers, airway blood flow, fluticasone, echocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 May 2014 (estimated)
- Results
- Posted 16 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Detailed description
With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.
Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers | Experimental | Procedure: echocardiogram plus albuterol, Procedure: airway blood flow plus albuterol, Drug: Fluticasone propionate, Drug: placeboparticipants with smoking history ( > 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation |
| non-smokers | Experimental | Procedure: echocardiogram plus albuterol, Procedure: airway blood flow plus albuterolhealthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.
Key exclusion criteria (7 listed)
- Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women
- Cardiovascular disease and/or use of cardiovascular medications
- Subjects with known beta-adrenergic agonist intolerance
- A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)
- Acute respiratory infection within four weeks prior to the study
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 |
|---|---|---|
| echocardiogram plus albuterolparticipants will performed echocardiogram before and 15 minutes after inhaled albuterol | Procedure or surgery | non-smokers, smokers |
| airway blood flow plus albuterolAlso: Qawparticipants will performed echocardiogram before and 15 minutes after inhaled albuterol | Procedure or surgery | non-smokers, smokers |
| Fluticasone propionateparticipant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer) | Drug | smokers |
| placeboparticipant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer). | Drug | smokers |
Primary outcome
Airway Blood Flow
Time frame: before and 15 minutes after albuterol inhalation
compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers
1 secondary outcome
Echocardiogram
Time frame: MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adam Wanner, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echocardiogram plus albuterol, airway blood flow plus albuterol and Fluticasone propionate in people with Smoking, run by University of Miami at 1 site in United States.
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 7 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 16 Dec 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Airway Blood Flow (time frame: before and 15 minutes after albuterol inhalation). 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 16 Dec 2016.