Paediatric and Adult African Spirometry II

NCT03038698 | Unknown

• 1 other identifier: BE295/16
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spirometry; normative values; health; south africa; children

Outcome Measures

Primary Outcomes (1)

• lung function in healthy adults and children

  lung function reference equations determination in healthy adults and children

  2 years

Eligibility Criteria

• Age: 5 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted in four regions in South Africa: KwaZulu Natal, Western Cape, Limpopo and Gauteng Province. Two sampling frames will be used with a paediatric and adult population. The paediatric sample frame will be school-going children (6 to 18 years) at primary and secondary schools during school days. For the adult sample, data will be collected on healthy adults age of 18 to 95 years, lung function testing will be conducted in conjunction with the South African Statistical Services (General Health Survey) a household surveys to ensure random population sampling from the four identified provinces from January 2016 to October 2017.

You may qualify if:

• Study involves African adults and children age 5 to 95 years.
• Study number of at least 300 'healthy' subjects \[7\] per population band as per table 1.
• Availability of essential background information for each subject (birth date, date of test, gender, height, weight, body mass index, socioeconomic status and ethnic group).
• Consent given for adults 18 years and above, and assent for children over the age of 8 years and parental/guardian consent for all children under the age of 18 years.

You may not qualify if:

• Inter-current upper or lower respiratory tract infection
• Chronic lung diseases: including asthma and chronic obstructive pulmonary disease
• Current or previous tuberculosis infection
• Myocardial infarction
• Stroke
• Muscular disorders
• Previous history of cardiac diseases
• Current smoker
• Past smoker with \>5 pack year of tobacco
• Previous lung surgery

Sponsors & Collaborators

• University of KwaZulu: lead
• AstraZeneca: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (1)

University of KwaZulu Natal

Durban, KwaZulu-Natal, 4013, South Africa

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 1, 2017
• Study Start: July 1, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: November 17, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)