Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide
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ClinicalTrials.gov Identifier: NCT01219738 |
Recruitment Status :
Completed
First Posted : October 13, 2010
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Budesonide 360ug Drug: Budesonide 720ug Drug: Budesonide 1440ug Drug: Budesonide720ug 4 times Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: budesonide 360ug
asthmatic subject received different doses of inhaled budesonide in random other
|
Drug: Budesonide 360ug
A single inhaled dose of 360ug budesonide from a DPI.
Other Name: Pulmicort Flexhaler |
Experimental: budesonide 720ug
asthmatic subject received different doses of inhaled budesonide in random other
|
Drug: Budesonide 720ug
A single inhaled dose of 720ug budesonide from a DPI.
Other Name: Pulmicort Flexhaler |
Experimental: budesonide 1440ug
asthmatic subject received different doses of inhaled budesonide in random other
|
Drug: Budesonide 1440ug
A single dose of 1440ug of the budesonide from DPI.
Other Name: Pulmicort Flexhaler |
Placebo Comparator: placebo
asthmatic subject received inhaled placebo
|
Drug: Budesonide720ug 4 times
720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
Other Name: Pulmicort Flexhaler |
Experimental: Budesonide720ug 4 times
asthmatic subject received 720ug of inhaled budesonide 4 times separated by 30 minutes.
|
Drug: Placebo
A single inhaled dose of placebo from a DPI.
Other Name: sugar pill |
- 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.
- Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: participant will be followed up to 6 hours after budesonide dose ]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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Twenty lifetime nonsmokers moderate or severe asthmatics; FEV1≥50 of predicted on the screening day
Exclusion Criteria:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219738
United States, Florida | |
Pulmonary Human Research Laboratory, University of Miami, Miller School of Medicine | |
Miami, Florida, United States, 33136 |
Principal Investigator: | Eliana Mendes, MD | University of Miami |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eliana Mendes, University of Miami |
ClinicalTrials.gov Identifier: | NCT01219738 |
Other Study ID Numbers: |
20071068 IRUSBUPF0002 ( Other Identifier: Sponsor ) |
First Posted: | October 13, 2010 Key Record Dates |
Results First Posted: | January 16, 2015 |
Last Update Posted: | January 16, 2015 |
Last Verified: | January 2015 |
Asthma, airway blood flow, budesonide, glucocorticosteroid. |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |