The COPD Attack Study

NCT05779384 | Completed

• 1 other identifier: MHREC1541
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to evaluate the frequency and predictors of exacerbations in COPD patient population in Uganda. The main questions it aims to answer are:-

1. 1.What is the proportion of frequent exacerbators (≥2/year) and what factors are associated with the frequent exacerbator phenotype?
2. 2.What is the frequency of exacerbations and what factors are correlated with exacerbation frequency? Participants will be asked to offer demographic ,clinical and exposure questions. Questionnaires assessing disease burden, and quality of life will be administered. Clinical measurements, and complete blood count will be collected ta baseline and on sick visits. Spirometry will be measured at baseline and on the last visit. Samples will be collected for storage. Participants will be followed up for one year.

Conditions

Pulmonary Disease, Chronic Obstructive; Exacerbation COPD

Outcome Measures

Primary Outcomes (1)

• Proportion and predictors of frequent exacerbators in a COPD patient population in Uganda

  The proportion of participants who had more than 2 exacerbations in the period of follow up and factors associated with these

  1 year period of follow up

Secondary Outcomes (1)

• Frequency and predictors of exacerbations (e.g infections, biomarkers) in this patient populations

  one year

Interventions

It was an observational study OTHER

data collected concerning the incidence of exacerbations

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will recruit COPD patients aged ≥ 30, diagnosed as specified on page 7. These patients will be identified during the screening phase as having GOLD airflow obstruction severity grades 1-4 and symptom/exacerbation risk categories A-D per the GOLD 2018 criteria (Figure 1). The cut-off of 30 years was chosen because prevalence studies in Ugandans indicated that COPD was prevalent in those as young as 30 years 18 .

You may qualify if:

• Age ≥30yrs
• COPD diagnosis as per protocol (page 7)
• Attending URAC clinic sites
• Written informed consent
• Able to fill in diary or has attendant who can help fill it out
• Willing to attend follow up visits as required by study

You may not qualify if:

• Active pulmonary tuberculosis
• Other important co-morbid disease likely to affect participation or outcomes, such as lung cancer, asthma and any other that may be deemed so, in which case be discussed on case by case basis by the investigational team.

Sponsors & Collaborators

• Makerere University: lead
• GlaxoSmithKline: collaborator
• University College, London: collaborator

Study Sites (2)

Makerere University college of health sciences, Mulago National Referal Hospital Complex

Kampala, 256, Uganda

Location

Makerere University Lung Institute

Kampala, 256, Uganda

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patricia Alupo, MMED

  alupopat@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: July 7, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

UG (2)