AsthmaNCT01219738
Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide
A study testing Budesonide 360ug, Budesonide 720ug and Budesonide 1440ug in people with Asthma, run by University of Miami at 1 site in United States.
Trial summary
Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide 360ug, Budesonide 720ug and Budesonide 1440ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Aug 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day
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 medication; Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; Acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; Use of systemic glucocorticosteroids within 4 weeks prior to the study; Daily ICS dose (fluticasone or budesonide) > 500ug; Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine
Miami, Florida, 33136
About this study
Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).
Read the detailed description
Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.
- Conditions
- Asthma
- Being tested
- Budesonide 360ug, Budesonide 720ug, Budesonide 1440ug, Budesonide720ug 4 times, Placebo
- Keywords
- Asthma, airway blood flow, budesonide, glucocorticosteroid.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide 360ugDrug
Also called Pulmicort Flexhaler
A single inhaled dose of 360ug budesonide from a DPI.
Budesonide 720ugDrug
Also called Pulmicort Flexhaler
A single inhaled dose of 720ug budesonide from a DPI.
Budesonide 1440ugDrug
Also called Pulmicort Flexhaler
A single dose of 1440ug of the budesonide from DPI.
Budesonide720ug 4 timesDrug
Also called Pulmicort Flexhaler
720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
PlaceboDrug
Also called sugar pill
A single inhaled dose of placebo from a DPI.
| Study group | Role | What they receive |
|---|---|---|
| budesonide 360ug | Experimental | asthmatic subject received different doses of inhaled budesonide in random other Receives: Drug: Budesonide 360ug |
| budesonide 720ug | Experimental | asthmatic subject received different doses of inhaled budesonide in random other Receives: Drug: Budesonide 720ug |
| budesonide 1440ug | Experimental | asthmatic subject received different doses of inhaled budesonide in random other Receives: Drug: Budesonide 1440ug |
| placebo | Placebo comparator | asthmatic subject received inhaled placebo Receives: Drug: Budesonide720ug 4 times |
| Budesonide720ug 4 times | Experimental | asthmatic subject received 720ug of inhaled budesonide 4 times separated by 30 minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Blood Flow (Qaw)
Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.
Measured: participants will be followed for 6 hours after budesonide dose
Secondary outcomes (1)
Forced Expiratory Volume in 1 Second (FEV1)
FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.
Measured: participant will be followed up to 6 hours after budesonide dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJul 2008
- Primary completionAug 2012
- Study completionAug 2012
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Eliana Mendes, University of Miami
- Investigators
- Eliana Mendes, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219738
- Sponsor's protocol ID
- 20071068
- Other IDs
- IRUSBUPF0002
- Status last verified
- Jan 2015
- First submitted
- 12 Oct 2010
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Horvath G, Sutto Z, Torbati A, Conner GE, Salathe M, Wanner A. Norepinephrine transport by the extraneuronal monoamine transporter in human bronchial arterial smooth muscle cells. Am J Physiol Lung Cell Mol Physiol. 2003 Oct;285(4):L829-37. doi: 10.1152/ajplung.00054.2003. Epub 2003 Jun 13.
PubMed 12807698Horvath G, Lieb T, Conner GE, Salathe M, Wanner A. Steroid sensitivity of norepinephrine uptake by human bronchial arterial and rabbit aortic smooth muscle cells. Am J Respir Cell Mol Biol. 2001 Oct;25(4):500-6. doi: 10.1165/ajrcmb.25.4.4559.
PubMed 11694456Mendes ES, Pereira A, Danta I, Duncan RC, Wanner A. Comparative bronchial vasoconstrictive efficacy of inhaled glucocorticosteroids. Eur Respir J. 2003 Jun;21(6):989-93. doi: 10.1183/09031936.03.00072402.
PubMed 12797493Brieva JL, Danta I, Wanner A. Effect of an inhaled glucocorticosteroid on airway mucosal blood flow in mild asthma. Am J Respir Crit Care Med. 2000 Jan;161(1):293-6. doi: 10.1164/ajrccm.161.1.9905068.
PubMed 10619834Mendes ES, Rebolledo P, Campos M, Wanner A. Immediate antiinflammatory effects of inhaled budesonide in patients with asthma. Ann Am Thorac Soc. 2014 Jun;11(5):706-11. doi: 10.1513/AnnalsATS.201307-220OC.
PubMed 24735128
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide
- ClinicalTrials.gov ID
- NCT01219738
- Acronym / sponsor ID
- 20071068
- Conditions
- Asthma
- Keywords
- Asthma, airway blood flow, budesonide, glucocorticosteroid.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glucocorticosteroids recently have been shown to have non-genomic actions that are plasma membrane-mediated and do not require gene transcription and translation. One of these non-genomic effects is the inhibition of adrenergic agonist transport into airway vascular smooth muscle cells with an increase of adrenergic agonist concentrations at adrenergic receptor sites and enhance the physiological effects of endogenous adrenergic agonists (e.g. locally released norepinephrine from noradrenergic neurons) or exogenous adrenergic agonists (e.g. inhaled beta-adrenergic agonists).
Detailed description
Inhaled glucocorticosteroids typically are not recommended for the treatment of acute asthma attacks. This practice is based on the fact that glucocorticosteroids by themselves do not cause rapid bronchodilation. However, the acute inhibition of adrenergic agonist disposal by the non-genomic action of glucocorticosteroids could lead to bronchial vasoconstriction by locally released norepinephrine thereby decongesting the airway wall, and potentiate the bronchodilator effect of a concomitantly administered beta-adrenergic agonist through the same mechanism. The purpose of this study is to assess the vasoconstrictive effects of single and repetitive high-dose budesonide inhalations in moderate to severe asthmatics who use inhaled glucocorticosteroids regularly. As a secondary endpoint, airway inflammation and airway function will also be measured with the expectation that acute improvements in airflow might be detectable as a result of airway decongestion, notably in subjects with moderately severe asthma who have lower baseline lung function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| budesonide 360ug | Experimental | Drug: Budesonide 360ugasthmatic subject received different doses of inhaled budesonide in random other |
| budesonide 720ug | Experimental | Drug: Budesonide 720ugasthmatic subject received different doses of inhaled budesonide in random other |
| budesonide 1440ug | Experimental | Drug: Budesonide 1440ugasthmatic subject received different doses of inhaled budesonide in random other |
| placebo | Placebo comparator | Drug: Budesonide720ug 4 timesasthmatic subject received inhaled placebo |
| Budesonide720ug 4 times | Experimental | Drug: Placeboasthmatic subject received 720ug of inhaled budesonide 4 times separated by 30 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day
Key exclusion criteria (1 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 medication; Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance; Acute respiratory infection and or acute exacerbation of asthma within four weeks prior to the study; Use of systemic glucocorticosteroids within 4 weeks prior to the study; Daily ICS dose (fluticasone or budesonide) > 500ug; Diabetes mellitus
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 |
|---|---|---|
| Budesonide 360ugAlso: Pulmicort FlexhalerA single inhaled dose of 360ug budesonide from a DPI. | Drug | budesonide 360ug |
| Budesonide 720ugAlso: Pulmicort FlexhalerA single inhaled dose of 720ug budesonide from a DPI. | Drug | budesonide 720ug |
| Budesonide 1440ugAlso: Pulmicort FlexhalerA single dose of 1440ug of the budesonide from DPI. | Drug | budesonide 1440ug |
| Budesonide720ug 4 timesAlso: Pulmicort Flexhaler720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes. | Drug | placebo |
| PlaceboAlso: sugar pillA single inhaled dose of placebo from a DPI. | Drug | Budesonide720ug 4 times |
Primary outcome
Airway Blood Flow (Qaw)
Time frame: participants will be followed for 6 hours after budesonide dose
Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.
1 secondary outcome
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: participant will be followed up to 6 hours after budesonide dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12807698Horvath G, Sutto Z, Torbati A, Conner GE, Salathe M, Wanner A. Norepinephrine transport by the extraneuronal monoamine transporter in human bronchial arterial smooth muscle cells. Am J Physiol Lung Cell Mol Physiol. 2003 Oct;285(4):L829-37. doi: 10.1152/ajplung.00054.2003. Epub 2003 Jun 13.
- Background: PubMed 11694456Horvath G, Lieb T, Conner GE, Salathe M, Wanner A. Steroid sensitivity of norepinephrine uptake by human bronchial arterial and rabbit aortic smooth muscle cells. Am J Respir Cell Mol Biol. 2001 Oct;25(4):500-6. doi: 10.1165/ajrcmb.25.4.4559.
- Background: PubMed 12797493Mendes ES, Pereira A, Danta I, Duncan RC, Wanner A. Comparative bronchial vasoconstrictive efficacy of inhaled glucocorticosteroids. Eur Respir J. 2003 Jun;21(6):989-93. doi: 10.1183/09031936.03.00072402.
- Background: PubMed 10619834Brieva JL, Danta I, Wanner A. Effect of an inhaled glucocorticosteroid on airway mucosal blood flow in mild asthma. Am J Respir Crit Care Med. 2000 Jan;161(1):293-6. doi: 10.1164/ajrccm.161.1.9905068.
- Derived from this study: PubMed 24735128Mendes ES, Rebolledo P, Campos M, Wanner A. Immediate antiinflammatory effects of inhaled budesonide in patients with asthma. Ann Am Thorac Soc. 2014 Jun;11(5):706-11. doi: 10.1513/AnnalsATS.201307-220OC.
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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.
Eliana Mendes, 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 Budesonide 360ug, Budesonide 720ug and Budesonide 1440ug in people with Asthma, 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 1 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 Jan 2015. 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. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2015). 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 (Qaw) (time frame: participants will be followed for 6 hours after budesonide dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219738, which also lists 5 linked publications.
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 Jan 2015.