Predictors of Acute Exacerbation in Patients With COPD - an Observational Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Prospective monitoring of a large variety of parameters: Patients will be recruited during an inpatient pulmonary rehabilitation program. This setting offers a unique opportunity to study the phenomenon of an acute exacerbation of the Chronic Obstructive Pulmonary Disease prior to the first visible clinical sign and further on to have a follow up of the underlying mechanisms. All COPD patients that are referred to the reference center for a rehabilitation program will be included after providing written informed consent. Prospectively, a wide range of measurements will be collected. If a patient develops an acute exacerbation there will be a comprehensive diagnostic assessment to differentiate between pulmonary, cardiac or cardio-pulmonary reasons for the exacerbation. The clinical diagnosis of an AECOPD will be made by a pulmonologist according to criteria of international guidelines within the first 24h of clinical symptoms suggestive of an exacerbation.

Study summary

Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD.

Eligibility

Primary outcome measure(s)

• Change from baseline laboratory parameters at day 21 — baseline and day 21
  following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
• Change from day 1 of an acute exacerbation in laboratory parameters at day 5 — day 1 and 5 in case of an acute exacerbation
  following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
• Change from baseline lung function at day 21 — baseline and day 21
  following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
• Change from day 1 of an acute exacerbation in lung function at day 5 — day 1 and 5 in case of an acute exacerbation
  following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
• Change from baseline Cardiac Doppler echocardiography at day 21 — baseline and day 21
  Left and right heart echocardiography will be performed
• Change from day 1 of an acute exacerbation in Cardiac Doppler echocardiography at day 5 — day 1 and 5 in case of an acute exacerbation
  Left and right heart echocardiography will be performed
• Change from baseline breath volatile organic compounds Analysis to day 4, 8, 11, 15 and 18 — day 1, 4, 8, 11, 15, 18
  breath samples will be analyzed by ion-mobility spectrometry and gaschromatography/mass spectrometry
• Change in baseline exercise Performance at day 21 — day 1 and 21
  following tests will be performed: 6-Minute walk test, sit-to-stand-test, Peak quadriceps and Hand grip force,
• Change from baseline Quality of life assessed by Short Form - 36 Questionnaire at days 21, day 180, day360, day 720 — baseline, day 21, day 180, day 360, day 720
  the scale of the physical and mental Health component summary score ranges from 0 to 100 Points with higher scores indicating better Quality of lif
• Change from baseline functional status assessed by Modified Medical Research Counsil score at days 21, day 180, day360, day 720 — baseline, day 21, day 180, day 360, day 720
  the score ranges from category 0 to 4 with higher scores indicating higher impairment in function status
• Change from baseline anxiety status assessed by Chronic Obstructive Pulmonary Disease Anxiety Questionnaire at days 21, day 180, day360, day 720 — baseline, day 21, day 180, day 360, day 720
  the total score ranges from 0 to 112 Points with higher scores indicating worse anxiety status
• Change from baseline Depression status assessed by Patient Health Questionnaire 9 at days 21, day 180, day360, day 720 — baseline, day 21, day 180, day 360, day 720
  the total score ranges from 0 to 27 Points with higher scores indicating worse Depression symptoms
• Change from baseline disease specific Quality of life assessed by Chronic Obstructive Pulmonary Disease Assessment Test at days 21, day 180, day360, day 720 — baseline, (day 1 and 5 in case of an acute exacerbation), day 21, day 180, day 360, day 720
  total score ranges from 0 to 40 points with higher scores indicating worse quality of life
• Self-reported patient diary — once daily from day 1 to day 21
  The EXAcerbations of Chronic pulmonary disease Tool will be used
• physical activity monitoring — continuous monitoring from day 1 to day 21
  Using the Actigraph device following Parameters will be collected: steps per day and physical activity levels
• Change in Survival Status from baseline at 6, 12 and 24 months — baseline, at 6, 12 and 24 months
  Survival Status will be assessed by phone calls
• cough events — Recording from day 1 to day 21 at night only
  Number of nocturnal cough events recorded by NELA sound device (Carepath)
• Self-reported patient symptom diary — Once daily from day 1 to day 21
  The COPD Exacerbation Recognition Tool (CERT) is used. The CERT asks about symptoms of increased cough, sputum production, shortness of breath, labored breathing, and reduced physical activity. The total score ranges from 0 (symptoms as usual) to 5 (severe deterioration compared to usual).

Trial sites (1)

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