An observational study in Obstructive Pulmonary Disease and Restrictive Pulmonary Disease, sponsored by Duke University. Recruiting at 1 site in Botswana. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Duke University · Observational
Chronic respiratory diseases like chronic obstructive pulmonary disease (COPD) are responsible for millions of deaths each year, the majority of which occur in low- and middle-income countries (LMICs). LMICs also have high rates of abnormal lung function, including restrictive spirometric pattern (RSP), which can precede the development of chronic respiratory diseases and is associated with all-cause mortality. Additionally, LMICs in sub-Saharan Africa are home to the majority of the world's population of people with HIV (PWH). HIV increases the risk of COPD and COPD associated mortality, but the mechanisms underlying this risk are incompletely understood.
To address the knowledge gap, the investigator propose a prospective cohort study to phenotype patterns of abnormal lung function and use multi-omics to identify associations between host-microbiome interactions, COPD, and lung function loss among adults with and without HIV in Botswana. The findings of this study will improve understanding of respiratory health and determinants of COPD among Batswana adults and contribute to the equitable development of novel COPD therapies by generating data from a population overrepresented in global COPD mortality but underrepresented in current COPD and microbiome research.
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. COPD affects nearly 300 million people globally and is the third leading cause of death.Despite advances in tobacco control programs, the prevalence of COPD is projected to increase as the global population ages, pneumonia incidence increases, and exposure to high levels of particulate air pollution persists. Additionally, COPD is a heterogenous disease with multiple partially understood phenotypes that exhibit varying responses to current therapies.Consequently, efforts to reduce incident COPD and COPD-associated mortality are complicated by challenges in reducing exposure to risk factors and an incomplete understanding of disease pathophysiology.
202 studies on the registry are indexed under Lung Diseases, Obstructive; 22 are open to participants now.
This study's planned enrollment of 900 is above the median of 185 across 48 observational studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adults 35 years and above with documented HIV status and without recent/active respiratory illness or inability to perform spirometry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with and without HIV
Duke Activity Status Index (DASI) score
The DASI will be assessed over time to determine pulmonary function.
Time frame: 60 months
Six minute walk test
A six minute walk test will be assessed over time to determine pulmonary function.
Time frame: 60 months
Plan to share: No — This not the research plan
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Dec 2029, 60 months after the start.
Of 25 observational studies under Lung Diseases, Obstructive, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 53. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
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