Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Sources of Variability in Peak Expiratory Flow

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005382
First received: May 25, 2000
Last updated: May 12, 2016
Last verified: November 2001
  Purpose
To provide information necessary for the development of standards for peak expiratory flow (PEF) test performance in populations studies.

Condition
Asthma
Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1995
Study Completion Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00005382     History of Changes
Other Study ID Numbers: 4287  R01HL051975 
Study First Received: May 25, 2000
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 26, 2016