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Paediatric and Adult African Spirometry II

NCT03038698 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2017-11-17

No results posted yet for this study

Summary

Pulmonary function testing is the most widely used tool for the diagnosis, severity assessment, management, risk factor categorization and follow-up of individuals with chronic lung disease. Africa has a high burden of infectious respiratory diseases which include tuberculosis, asthma and human immunodeficiency virus-related lung disease. Coupled with this is an increasing burden of non-communicable respiratory diseases; which include chronic obstructive pulmonary disease, emphysema, bronchiectasis and asthma. A proviso to the use of lung function testing is the determination of "normal" values; which are determined for age, gender, height and ethnicity for the relevant population. It is well recognised that the comparison of an individual patients' results to an ethnically inappropriate population may lead to the under or -over diagnosis of disease, inappropriate treatments and result in increased burden on individuals, their families and the healthcare system.

The investigators therefore propose to conduct a prospective well-designed study to include a representative sample of both adults and children (4000); to verify the validity of the retrospective pilot data, in a South African population.

Conditions

  • Lung Diseases

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Medical Research Council, South Africa

    collaborator OTHER

  • University of KwaZulu

    lead OTHER

Eligibility

Min Age
5 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038698 on ClinicalTrials.gov