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

NCT04140097 | Active Not Recruiting

• 1 other identifier: PACE Trial
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD; COPD Exacerbation; COPD Exacerbation Acute

Keywords

Predictor; Development; Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (18)

• Change from baseline laboratory parameters at 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

  baseline and day 21

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

  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

  day 1 and 5 in case of an acute exacerbation

• Change from baseline lung function at day 21

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

  baseline and day 21

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

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

  day 1 and 5 in case of an acute exacerbation

• Change from baseline Cardiac Doppler echocardiography at day 21

  Left and right heart echocardiography will be performed

  baseline and day 21

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

  Left and right heart echocardiography will be performed

  day 1 and 5 in case of an acute exacerbation

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

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

  day 1, 4, 8, 11, 15, 18

• Change in baseline exercise Performance at day 21

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

  day 1 and 21

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

  baseline, day 21, day 180, day 360, day 720

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

  the score ranges from category 0 to 4 with higher scores indicating higher impairment in function status

  baseline, day 21, day 180, day 360, day 720

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

  the total score ranges from 0 to 112 Points with higher scores indicating worse anxiety status

  baseline, day 21, day 180, day 360, day 720

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

  the total score ranges from 0 to 27 Points with higher scores indicating worse Depression symptoms

  baseline, day 21, day 180, day 360, day 720

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

  total score ranges from 0 to 40 points with higher scores indicating worse quality of life

  baseline, (day 1 and 5 in case of an acute exacerbation), day 21, day 180, day 360, day 720

• Self-reported patient diary

  The EXAcerbations of Chronic pulmonary disease Tool will be used

  once daily from day 1 to day 21

• physical activity monitoring

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

  continuous monitoring from day 1 to day 21

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

  Survival Status will be assessed by phone calls

  baseline, at 6, 12 and 24 months

• cough events

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

  Recording from day 1 to day 21 at night only

• Self-reported patient symptom diary

  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).

  Once daily from day 1 to day 21

Study Arms (2)

COPD patients with acute exacerbation

Other: Prospective monitoring of a large variety of parameters

COPD patients without acute exacerbation

Other: Prospective monitoring of a large variety of parameters

Interventions

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.

COPD patients with acute exacerbation; COPD patients without acute exacerbation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- current primary diagnosis of asthma

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• GlaxoSmithKline GmbH & Co. KG (Munich, Germany): collaborator
• Coordinating Center for Clinical Trials (KKS; Philipps-University of Marburg, Germany): collaborator
• Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria): collaborator
• Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany): collaborator
• Institute of Laboratory Medicine and Pathobiochemistry, Molecular Diagnostics, Philipps University Marburg (Marburg, Germany): collaborator

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

Related Publications (2)

• Gloeckl R, Jones PW, Kroll D, Jarosch I, Schneeberger T, Claussen J, Schmidt P, Vogelmeier CF, Kenn K, Koczulla AR. Can Patient Education Lead the Way? Head-To-Head Comparison of EXACT and CERT for Early Recognition of Acute COPD Exacerbations. Respirology. 2025 Nov 30. doi: 10.1002/resp.70170. Online ahead of print.

  PMID: 41320645 DERIVED

• Kenn K, Gloeckl R, Leitl D, Schneeberger T, Jarosch I, Hitzl W, Alter P, Sczepanski B, Winterkamp S, Boensch M, Schade-Brittinger C, Skevaki C, Holz O, Jones PW, Vogelmeier CF, Koczulla AR. Protocol for an observational study to identify potential predictors of an acute exacerbation in patients with chronic obstructive pulmonary disease (the PACE Study). BMJ Open. 2021 Feb 8;11(2):e043014. doi: 10.1136/bmjopen-2020-043014.

  PMID: 33558356 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 25, 2019
• Study Start: February 26, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

DE (1)