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Bronchodilator Responsiveness in Healthy Young Adults Using Forced Oscillations Technique (FOT)

This study has been completed.
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01067534
First received: February 10, 2010
Last updated: January 18, 2011
Last verified: April 2010
History of Changes
  Purpose

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

  1. 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
  2. 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.
  3. 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:

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
  Show Detailed Description

  Eligibility

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
  Contacts and Locations
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
  More Information

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