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Trial record 17 of 101 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

Paediatric and Adult African Spirometry II (PAASII)

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ClinicalTrials.gov Identifier: NCT03038698
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
AstraZeneca
Medical Research Council, South Africa
Information provided by (Responsible Party):
University of KwaZulu

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.


Condition or disease
Lung Diseases

Detailed Description:

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 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 [1,2]. The management of these colliding epidemics requires correct diagnosis and management in order to ensure adequate resource allocation and avoidance of unnecessary costs.

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 [3]. These "normal' values should also take into account the normal lung function decline associated and the aging process. 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 [4-6]. There are numerous published reference equations, but the recently published Global Lung Initiative multi-ethnic reference equations published in 2012(GLI2012) collated the largest spirometry data set from individuals aged 2.5 to 95 years [7]. The innovation in GLI2012 was that it allowed for the smooth transitioning of data from childhood adulthood using sophisticated statistical modelling.

The investigators have previously collated data in phase 1 of this study using the GLI methodology on published African spirometry data from 26 594 individuals, and found a wide variation in predicted z-scores when fitting the African data to GLI2012, with a fairly good match between the black African males and African-Americans [15]. This dataset was skewed as due to the large number of African males and with a disproportionally larger contribution of data from North Africa and therefore requires confirmation. 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.


Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Paediatric and Adult African Spirometry II: A Determination of Reference Equation in South African Children and Adults
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases




Primary Outcome Measures :
  1. lung function in healthy adults and children [ Time Frame: 2 years ]
    lung function reference equations determination in healthy adults and children



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038698


Locations
South Africa
University of KwaZulu Natal Recruiting
Durban, KwaZulu Natal, South Africa, 4013
Contact: Refiloe Masekela, PhD    +27312604399    masekelar@ukzn.ac.za   
Contact: Diane Pillay    +27312604345    pillayd31@ukzn.ac.za   
Sponsors and Collaborators
University of KwaZulu
AstraZeneca
Medical Research Council, South Africa

Responsible Party: University of KwaZulu
ClinicalTrials.gov Identifier: NCT03038698     History of Changes
Other Study ID Numbers: BE295/16
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All results of the study will be published in a peer-reviewed journal

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of KwaZulu:
spirometry
normative values
health
south africa
children

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases