Bronchodilator Responsiveness in Healthy Young Adults Using Forced Oscillations Technique (FOT)
This study has been completed.
Sponsor:
University of Patras
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01067534
First received: February 10, 2010
Last updated: January 18, 2011
Last verified: April 2010
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Studies evaluating response to bronchodilation in flow-volume spirometry and/or by forced oscillations technique (FOT), have been conduced in subjects with obstructive airways diseases. Less is known about bronchodilation responses, assessed by both spirometry and FOT in healthy young subjects.
The purpose of the present study is
- to determine the range of the bronchodilation response in terms of changes in selected spirometric parameters in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and spirometric determinants
- to determine the range and characteristics of bronchodilation response using pseudorandom FOT in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and oscillometric determinants.
- to compare and correlate eventual changes in spirometric and oscillometric parameters.
The investigators hypothesize that exists a normal variation in spirometric and oscillometric parameters after bronchodilation, and that these parameters are correlated.
Condition | Intervention |
---|---|
Bronchodilation |
Drug: Salbutamol |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
Official Title: | Assessment of Bronchodilator Responsiveness in Healthy Young Adults Using Forced Oscillations |
Resource links provided by NLM:
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
Further study details as provided by University of Patras:
Primary Outcome Measures:
- Bronchodilation responses, assessed by both spirometry and FOT, in healthy young subjects after receiving salbutamol or placebo [ Time Frame: 15 minutes after inhalation of salbutamol or placebo ] [ Designated as safety issue: No ]
Estimated Enrollment: | 100 |
Study Start Date: | February 2010 |
Study Completion Date: | January 2011 |
Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Salbutamol
Inhaler salbutamol 0,1 mg/dose - 4 doses=0,4 mg
Other Name: Aerolin
![](https://webarchive.library.unt.edu/web/20121019014532im_/http://www.clinicaltrials.gov/ct2/html/images/frame/plus.gif)
![](https://webarchive.library.unt.edu/web/20121019014532im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 20 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy non-smoking young adults
Exclusion Criteria:
- Respiratory symptoms
- Respiratory disease
- Respiratory medication
- Smoking
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01067534
Locations
Greece | |
University Hospital of Patras | |
Patras, Greece, 26504 |
Sponsors and Collaborators
University of Patras
Investigators
Study Director: | Michael Anthracopoulos, MD | University Hospital of Patras, Greece |
Principal Investigator: | Sotirios Fouzas, MD | University Hospital of Patras, Greece |
Principal Investigator: | Konstantinos Bolis, MD | University Hospital of Patras, Greece |
![](https://webarchive.library.unt.edu/web/20121019014532im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Michael Anthracopoulos, Assoc. Prof. of Pediatrics and Pediatric Pulmonology, University of Patras, Patras, Greece |
ClinicalTrials.gov Identifier: | NCT01067534 History of Changes |
Other Study ID Numbers: | FOT_PATR_2010 |
Study First Received: | February 10, 2010 |
Last Updated: | January 18, 2011 |
Health Authority: | Greece: National Organization of Medicines |
Additional relevant MeSH terms:
Albuterol Bronchodilator Agents Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on October 17, 2012