Pulmonary Disease, Chronic ObstructiveCOPANCT05779384
The COPD Attack Study
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation COPD, run by Makerere University at 2 sites in Uganda.
Trial 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. What is the proportion of frequent exacerbators (≥2/year) and what factors are associated with the frequent exacerbator phenotype? 2. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exacerbation COPD
- What is being tested?
- It was an observational study
- How many people
- 323 participants
- Where
- 2 sitesUganda
- Study dates
- 7 Jul 2019to 30 Mar 2021
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Makerere University college of health sciences, Mulago National Referal Hospital Complex
Kampala, 256
Makerere University Lung Institute
Kampala, 256
About this study
Official title: Frequency and Predictors of Exacerbations Within a COPD Population in Uganda
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:-
- What is the proportion of frequent exacerbators (≥2/year) and what factors are associated with the frequent exacerbator phenotype?
- 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.
Read the detailed description
In this prospective observational study aimed at evaluating the frequency and predictors of exacerbations in a COPD population, the following were the objectives.
Primary objective
- To estimate the proportion and predictors of frequent COPD exacerbations in Ugandans with COPD. Secondary objective(s)
- To determine the frequency and predictors of exacerbations among COPD patients in Uganda
- To evaluate the aetiologies of COPD exacerbations including eosinophilia, and bacterial causes.
- To evaluate outcomes such as quality of life, lung function decline in patients with exacerbations by frequency of the exacerbations. COPD will be diagnosed as follows Definitions and diagnostic criteria for COPD and its grading, and that of an exacerbation have been provided by the GOLD guidelines 4 . This study will use the GOLD definitions and classifications. As per GOLD 2018 guidelines 4 , COPD will be considered in any patient with appropriate spirometry who has dyspnea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease.
GOLD 2018 definition of an exacerbation:
An acute worsening in respiratory symptoms that results in additional therapy. A) Mild exacerbation: Requires additional treatment with short acting bronchodilators only B) Moderate exacerbation: Requires additional treatment with short acting bronchodilators plus antibiotics and / or oral corticosteroids C) Severe exacerbation: Requires hospitalization or visit to emergency room. participants will be followed up at three monthly intervals, except when they have had a severe exacerbation, where they will be followed up at two weekly intervals until they stabilise.
During the follow up visit, participant's COPD diaries will be evaluated for exacerbation length, severity and frequency as well as health care utilization. Additionally the CAT, CCQ and MRC dyspnoea scale questionaires, to evaluate the impact of COPD on quality of life will be administered. Finally lung function will be evaluated by spirometry.
- Being tested
- It was an observational study
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It was an observational studyOther
data collected concerning the incidence of exacerbations
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year period of follow up
Secondary outcomes (1)
Frequency and predictors of exacerbations (e.g infections, biomarkers) in this patient populations
The frequency of exacerbations that participants developed and the factors associated with these
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start7 Jul 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, University College, London
- Responsible party
- Sponsor
- Investigators
- Patricia Alupo, MMED, Principal investigator, alupopat@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779384
- Sponsor's protocol ID
- MHREC1541
- Acronym
- COPA
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Predictors of Exacerbations Within a COPD Population in Uganda
- ClinicalTrials.gov ID
- NCT05779384
- Acronym / sponsor ID
- COPA / MHREC1541
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, University College, London
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 22 Mar 2023 (actual)
- 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.
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:-
- What is the proportion of frequent exacerbators (≥2/year) and what factors are associated with the frequent exacerbator phenotype?
- 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.
Detailed description
In this prospective observational study aimed at evaluating the frequency and predictors of exacerbations in a COPD population, the following were the objectives.
Primary objective
- To estimate the proportion and predictors of frequent COPD exacerbations in Ugandans with COPD. Secondary objective(s)
- To determine the frequency and predictors of exacerbations among COPD patients in Uganda
- To evaluate the aetiologies of COPD exacerbations including eosinophilia, and bacterial causes.
- To evaluate outcomes such as quality of life, lung function decline in patients with exacerbations by frequency of the exacerbations. COPD will be diagnosed as follows Definitions and diagnostic criteria for COPD and its grading, and that of an exacerbation have been provided by the GOLD guidelines 4 . This study will use the GOLD definitions and classifications. As per GOLD 2018 guidelines 4 , COPD will be considered in any patient with appropriate spirometry who has dyspnea, chronic cough or sputum production, and/or a history of exposure to risk factors for the disease.
GOLD 2018 definition of an exacerbation:
An acute worsening in respiratory symptoms that results in additional therapy. A) Mild exacerbation: Requires additional treatment with short acting bronchodilators only B) Moderate exacerbation: Requires additional treatment with short acting bronchodilators plus antibiotics and / or oral corticosteroids C) Severe exacerbation: Requires hospitalization or visit to emergency room. participants will be followed up at three monthly intervals, except when they have had a severe exacerbation, where they will be followed up at two weekly intervals until they stabilise.
During the follow up visit, participant's COPD diaries will be evaluated for exacerbation length, severity and frequency as well as health care utilization. Additionally the CAT, CCQ and MRC dyspnoea scale questionaires, to evaluate the impact of COPD on quality of life will be administered. Finally lung function will be evaluated by spirometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It was an observational studydata collected concerning the incidence of exacerbations | Other | – |
Primary outcome
Proportion and predictors of frequent exacerbators in a COPD patient population in Uganda
Time frame: 1 year period of follow up
The proportion of participants who had more than 2 exacerbations in the period of follow up and factors associated with these
1 secondary outcome
Frequency and predictors of exacerbations (e.g infections, biomarkers) in this patient populations
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Recruiting
Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
COPD - Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation
Recruiting
Study on Impact of Maximal Strength Training in Patients With COPD
Chronic Obstructive Pulmonary Disease
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.
Patricia Alupo, MMED principal investigator
alupopat@gmail.com
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Exacerbation COPD, run by Makerere University at 2 sites in Uganda.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion and predictors of frequent exacerbators in a COPD patient population in Uganda (time frame: 1 year period of follow up). 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 22 Mar 2023.