Sources of Variability in Peak Expiratory Flow
Primary Purpose
Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Asthma
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005382
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005382
Brief Title
Sources of Variability in Peak Expiratory Flow
Study Type
Observational
2. Study Status
Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
July 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To provide information necessary for the development of standards for peak expiratory flow (PEF) test performance in populations studies.
Detailed Description
BACKGROUND:
While PEF has routinely been applied in the diagnosis and management of asthma, scientists were finding new applications for PEF as both a clinical and epidemiologic tool for following individuals with pulmonary diseases, studying the natural history of chronic obstructive pulmonary disease, and evaluating the impact of environmental exposures on lung function. Yet the standardization of the PEF measurement lagged behind its application.
The little attention paid to the performance characteristics of the PEF maneuver contrasted sharply with the efforts to standardize measurement procedures for FEV1 and FVC. The American Thoracic Society devoted a great deal of attention to studying these measures and published guidelines for the standardization of their measurement. These guidelines included detailed protocols for calibrating equipment, administering the tests, determining reproducibility, and interpreting results.
The research provided data on the optimal number of trials per test session, the difference between a PEF performed during a full forced expiratory effort and that resulting from a short blast, the impact of test supervision on test performance, and the reproducibility of the PEF measurement.
DESIGN NARRATIVE:
A baseline survey of ventilatory function was performed using spirometry. PEF was measured daily with a mini-Wright Peak Flow Meter over a period of several weeks in a study of 201 normals (staff, faculty and graduate students at the University of Massachusetts Lowell). Serial PEF data were collected on a group of mild asthmatics identified in a local occupational medicine clinic. Finally, performance characteristics were examined in serial PEF data from two existing occupational cohort studies.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
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Sources of Variability in Peak Expiratory Flow
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