Lung DiseasesPAASIINCT03038698
Paediatric and Adult African Spirometry II
An observational study of Lung Diseases, run by University of KwaZulu at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases
- How many people
- 4,000 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jul 2017to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 95 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Previous history of cardiac diseases
- Current smoker
- Past smoker with >5 pack year of tobacco
- Previous lung surgery
Trial locations and contacts
1 site in 1 country.
South Africa1 site, 1 recruiting
- Recruiting
University of KwaZulu Natal
Durban, KwaZulu-Natal, 4013
Refiloe Masekela, PhD, +27312604399, masekelar@ukzn.ac.za
Diane Pillay, +27312604345, pillayd31@ukzn.ac.za
About this study
Official title: Paediatric and Adult African Spirometry II: A Determination of Reference Equation in South African Children and Adults
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.
Read the 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.
- Conditions
- Lung Diseases
- Keywords
- spirometry, normative values, health, south africa, children
- Medical subject headings
- Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
lung function in healthy adults and children
lung function reference equations determination in healthy adults and children
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start1 Jul 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Medical Research Council, South Africa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038698
- Sponsor's protocol ID
- BE295/16
- Acronym
- PAASII
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results of the study will be published in a peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric and Adult African Spirometry II: A Determination of Reference Equation in South African Children and Adults
- ClinicalTrials.gov ID
- NCT03038698
- Acronym / sponsor ID
- PAASII / BE295/16
- Conditions
- Lung Diseases
- Keywords
- spirometry, normative values, health, south africa, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- AstraZeneca, Medical Research Council, South Africa
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lung function in healthy adults and children
Time frame: 2 years
lung function reference equations determination in healthy adults and children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: No. All results of the study will be published in a peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University of KwaZulu at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung function in healthy adults and children (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.