The COPD Attack Study
Condition: Pulmonary Disease, Chronic Obstructive; Exacerbation COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Observational

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. 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

      1. To estimate the proportion and predictors of frequent COPD exacerbations in Ugandans with
      COPD. Secondary objective(s)

        1. To determine the frequency and predictors of exacerbations among COPD patients in Uganda

        2. To evaluate the aetiologies of COPD exacerbations including eosinophilia, and bacterial
           causes.

        3. 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.
    

Intervention name(s): It was an observational study
Intervention type(s): Other
Intervention description(s): data collected concerning the incidence of exacerbations
Observational model: Cohort
Time perspective: Prospective
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 .
      
Biospecimen description: 
      serum