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

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ClinicalTrials.gov Identifier: NCT04140097
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
GlaxoSmithKline GmbH & Co. KG (Munich, Germany)
Coordinating Center for Clinical Trials (KKS; Philipps-University of Marburg, Germany)
Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria)
Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)
Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg (Marburg, Germany)
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

Brief 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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease COPD COPD Exacerbation COPD Exacerbation Acute Other: Prospective monitoring of a large variety of parameters

Detailed Description:

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):

  1. To identify potential mechanisms explaining the nature and composition of an acute exacerbation in COPD patients
  2. To identify and differentiate patterns of acute COPD exacerbation versus cardiac failure in COPD patients
  3. 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")
  4. To identify parameters influencing mortality and other adverse events in the total study cohort at 6, 12 and 24 months follow up

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Study Type : Observational
Estimated Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Acute Exacerbation in Patients With COPD - an Observational Study (PACE Trial)
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : February 25, 2023
Estimated Study Completion Date : February 25, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort Intervention/treatment
COPD patients with acute exacerbation Other: 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.

COPD patients without acute exacerbation Other: 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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Chronic Obstructive Pulmonary Disease that are referred to an inpatient pulmonary rehabilitation program at the reference center.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140097


Contacts
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Contact: Rainer Gloeckl, PhD +49-8652-931630 rgloeckl@schoen-klinik.de

Locations
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Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schoenau Am Koenigssee, Germany, 83471
Contact: Rainer Gloeckl, PhD    08652-931630    rgloeckl@schoen-klinik.de   
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
GlaxoSmithKline GmbH & Co. KG (Munich, Germany)
Coordinating Center for Clinical Trials (KKS; Philipps-University of Marburg, Germany)
Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria)
Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)
Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg (Marburg, Germany)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Klaus Kenn, Professor, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT04140097    
Other Study ID Numbers: PACE Trial
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
Predictor
Development
Pulmonary Rehabilitation
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases