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NCT Number: NCT04140097

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD COPD Exacerbation COPD Exacerbation Acute Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

About this study

In total, 355 COPD patients will be included prospectively to this study during a 3-week inpatient pulmonary rehabilitation programme at the Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, (Germany). All patients will be closely monitored from admission to the study. Measures of lung function, blood samples, breath sampling, exercise tests, physical activity monitoring, cardiac parameters, quality of life and a symptom diary will be recorded regularly. Prior knowledge from this programme suggest that about 15% of patients will develop an AECOPD during this observational phase. If a patient develops an AECOPD there will be a comprehensive diagnostic assessment to differentiate between cardiac, pulmonary or cardio-pulmonary reasons for the AECOPD and to identify the type of exacerbation. The clinical diagnosis and management of an AECOPD will be determined by a pulmonologist according to criteria of international guidelines within the first 24h after the onset of clinical symptoms suggestive of an exacerbation. Collected clinical data from the days prior to AECOPD will be analyzed comprehensively to identify parameters with high prediction power for AECOPD. Furthermore, patients will perform follow-up measures at 6, 12 and 24 months following the initial observational phase (PR phase).

A wide range of predictor screening methods will be applied to identify significant predictors including cross tabulation tables, correlations, generalized linear models, mixed models, generalized estimation equation models and various predictor screening methods based on variable selection algorithms.

Study objectives Primary endpoint: To prospectively identify potential early, respiratory and/ or cardiac clinical predictors, laboratory parameters, breath print analyses and/ or changes in lung function and physical activity prior to an AECOPD in COPD patients.

Secondary endpoint(s):

  • To identify potential mechanisms explaining the nature and composition of an acute exacerbation in COPD patients
  • To identify and differentiate patterns of acute COPD exacerbation versus cardiac failure in COPD patients
  • To investigate the potential role of an electronic-nose to capture exhaled breath metabolomic profiles for the early detection of an acute exacerbation in COPD patients ("COPD pre exacerbation breath print")
  • To identify parameters influencing mortality and other adverse events in the total study cohort at 6, 12 and 24 months follow up

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • confirmed diagnosis of Chronic Obstructive Pulmonary Disease according to Global Association for Obstructive Lung Disease stage II to IV
  • the ability to follow the rehabilitation protocol
  • provided written informed consent

Exclusion criteria

  • current primary diagnosis of asthma

Treatment and study plan

Prospective monitoring of a large variety of parameters

Other

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.

Primary outcomes

  1. Change from baseline laboratory parameters at day 21

    Time frame: 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

  2. Change from day 1 of an acute exacerbation in laboratory parameters at day 5

    Time frame: 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

  3. Change from baseline lung function at day 21

    Time frame: baseline and day 21

    following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume

  4. Change from day 1 of an acute exacerbation in lung function at day 5

    Time frame: 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

  5. Change from baseline Cardiac Doppler echocardiography at day 21

    Time frame: baseline and day 21

    Left and right heart echocardiography will be performed

  6. Change from day 1 of an acute exacerbation in Cardiac Doppler echocardiography at day 5

    Time frame: day 1 and 5 in case of an acute exacerbation

    Left and right heart echocardiography will be performed

  7. Change from baseline breath volatile organic compounds Analysis to day 4, 8, 11, 15 and 18

    Time frame: day 1, 4, 8, 11, 15, 18

    breath samples will be analyzed by ion-mobility spectrometry and gaschromatography/mass spectrometry

  8. Change in baseline exercise Performance at day 21

    Time frame: day 1 and 21

    following tests will be performed: 6-Minute walk test, sit-to-stand-test, Peak quadriceps and Hand grip force,

  9. Change from baseline Quality of life assessed by Short Form - 36 Questionnaire at days 21, day 180, day360, day 720

    Time frame: 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

  10. Change from baseline functional status assessed by Modified Medical Research Counsil score at days 21, day 180, day360, day 720

    Time frame: 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

  11. Change from baseline anxiety status assessed by Chronic Obstructive Pulmonary Disease Anxiety Questionnaire at days 21, day 180, day360, day 720

    Time frame: 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

  12. Change from baseline Depression status assessed by Patient Health Questionnaire 9 at days 21, day 180, day360, day 720

    Time frame: 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

  13. Change from baseline disease specific Quality of life assessed by Chronic Obstructive Pulmonary Disease Assessment Test at days 21, day 180, day360, day 720

    Time frame: 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

  14. Self-reported patient diary

    Time frame: once daily from day 1 to day 21

    The EXAcerbations of Chronic pulmonary disease Tool will be used

  15. physical activity monitoring

    Time frame: continuous monitoring from day 1 to day 21

    Using the Actigraph device following Parameters will be collected: steps per day and physical activity levels

  16. Change in Survival Status from baseline at 6, 12 and 24 months

    Time frame: baseline, at 6, 12 and 24 months

    Survival Status will be assessed by phone calls

  17. cough events

    Time frame: Recording from day 1 to day 21 at night only

    Number of nocturnal cough events recorded by NELA sound device (Carepath)

  18. Self-reported patient symptom diary

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)
  • GlaxoSmithKline GmbH & Co. KG (Munich, Germany)
  • Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg (Marburg, Germany)
  • Philipps University Marburg
  • Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria)

Registry information

Official study title

Predictors of Acute Exacerbation in Patients With COPD - an Observational Study (PACE Trial)

Acronym: PACE

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Oct 25, 2019
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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