NCT01067534

Brief Summary

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. 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. 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. 3.to compare and correlate eventual changes in spirometric and oscillometric parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 19, 2011

Status Verified

April 1, 2010

Enrollment Period

11 months

First QC Date

February 10, 2010

Last Update Submit

January 18, 2011

Conditions

Bronchodilation

Outcome Measures

Primary Outcomes (1)

  • Bronchodilation responses, assessed by both spirometry and FOT, in healthy young subjects after receiving salbutamol or placebo

    15 minutes after inhalation of salbutamol or placebo

Interventions

SalbutamolDRUG

Inhaler salbutamol 0,1 mg/dose - 4 doses=0,4 mg

Also known as: Aerolin

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-smoking young adults

You may not qualify if:

  • Respiratory symptoms
  • Respiratory disease
  • Respiratory medication
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, 26504, Greece

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Michael Anthracopoulos, MD

    University Hospital of Patras, Greece

    STUDY DIRECTOR

  • Sotirios Fouzas, MD

    University Hospital of Patras, Greece

    PRINCIPAL INVESTIGATOR

  • Konstantinos Bolis, MD

    University Hospital of Patras, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 19, 2011

Record last verified: 2010-04

Locations

GR(1)