Trial Outcomes & Findings for The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids. (NCT NCT03611777)
NCT ID: NCT03611777
Last Updated: 2021-04-08
Results Overview
Percentage of patients currently on ICS who did not have moderate or severe exacerbation in the year prior to the study visit, (i.e. within the last 365 days before the study visit). Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
COMPLETED
901 participants
1 year prior to study visit, data collected at study visit (1 day).
2021-04-08
Participant Flow
Non-interventional, cross-sectional, multicenter study to describe the chronic obstructive pulmonary disease (COPD) patient profile of patients treated with or without Inhaled CorticoSteroids (ICS) in primary care, in Spain.
Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study.
Participant milestones
| Measure |
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Not Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Overall Study
STARTED
|
432
|
469
|
|
Overall Study
COMPLETED
|
432
|
469
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.
Baseline characteristics by cohort
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Not Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) not treated with Inhaled CorticoSteroids (ICS).
|
Total
n=901 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.44 Years
STANDARD_DEVIATION 10.27 • n=5 Participants
|
70.55 Years
STANDARD_DEVIATION 9.37 • n=7 Participants
|
70.97 Years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
343 Participants
n=5 Participants
|
381 Participants
n=7 Participants
|
724 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
427 Participants
n=5 Participants
|
467 Participants
n=7 Participants
|
894 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Argentinian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Gypsy
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS who were treated with ICS at study visit.
Percentage of patients currently on ICS who did not have moderate or severe exacerbation in the year prior to the study visit, (i.e. within the last 365 days before the study visit). Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study Visit
|
62.5 Percentage of participants
Interval 57.8 to 67.0
|
—
|
SECONDARY outcome
Timeframe: 1 year prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS who were treated with ICS at study visit.
Percentage of patients currently on ICS who have had moderate or severe exacerbation in the year prior to the study visit, (i.e. within the last 365 days before the study visit). Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study Visit
|
37.5 Percentage of participants
Interval 32.9 to 42.3
|
—
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS who were treated with ICS at study visit.
Percentage of patients with chronic obstructive pulmonary disease (COPD) treated with Inhaled CorticoSteroids (ICS) at the time of study visit with or without moderate or severe exacerbations, in the previous 2 years before the study visit. Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, in the Previous 2 Years Before the Study Visit
With moderate or severe exacerbations
|
46.8 Percentage of participants
|
—
|
|
Percentage of Patients Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, in the Previous 2 Years Before the Study Visit
Without moderate or severe exacerbations
|
53.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year and 2 years prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS who were not treated with ICS at study visit.
Percentage of patients with chronic obstructive pulmonary disease (COPD) treated with Inhaled CorticoSteroids (ICS) at the time of study visit with or without moderate or serve exacerbations, both in the previous 1 year and previous 2 years before the study visit. Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit
1 year prior study visit: With moderate or severe exacerbations
|
16.6 Percentage of participants
|
—
|
|
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit
1 year prior study visit: Without moderate or severe exacerbations
|
83.4 Percentage of participants
|
—
|
|
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit
2 years prior study visit: With moderate or severe exacerbation
|
22.8 Percentage of participants
|
—
|
|
Percentage of Patients Not Treated With Inhaled CorticoSteroids (ICS) at the Time of Study Visit With or Without Moderate or Severe Exacerbations, Both in the Previous 1 Year and Previous 2 Years Before the Study Visit
2 years prior study visit: Without moderate or severe exacerbations
|
77.2 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year and 2 years prior to study visit, data collected at study visit.Population: Patients in the FAS who were treated with ICS at study visit.
Number of moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) patients treated with ICS at the time of study visit, both in previous 1 year and previous 2 years before the study visit. Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Number of Moderate or Severe Exacerbations in Patients Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit
1 year prior study visit
|
0.72 Exacerbations
Standard Deviation 1.23
|
—
|
|
Number of Moderate or Severe Exacerbations in Patients Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit
2 years prior to study visit
|
1.27 Exacerbations
Standard Deviation 1.99
|
—
|
SECONDARY outcome
Timeframe: 1 year and 2 years prior to study visit, data collected at study visit.Population: Patients in the FAS who were not treated with ICS at study visit.
Number of moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) patients not treated with ICS at the time of study visit, both in previous 1 year and previous 2 years before the study visit.Data related to history and details of exacerbations and ICS treatment, as well as data on current ICS treatment was obtained from medical charts. Moderate exacerbation: increase in, or new onset of, ≥ 2 respiratory symptoms (cough, sputum, dyspnea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading the patient's attending physician to initiate treatment with systemic corticosteroids and/or antibiotics. Severe exacerbation: increase in or new onset of ≥ 2 respiratory symptoms (cough, sputum, dyspnoea, wheezing, chest tightness) with ≥ 1 symptom lasting ≥ 3 days and leading to patient's hospitalization.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Number of Moderate or Severe Exacerbations in Patients Not Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit
1 year prior study visit
|
0.26 Exacerbations
Standard Deviation 0.77
|
—
|
|
Number of Moderate or Severe Exacerbations in Patients Not Treated With Inhaled Corticosteroids (ICS) at the Time of Study Visit, Both in Previous 1 Year and Previous 2 Years Before the Study Visit
2 years prior study visit
|
0.43 Exacerbations
Standard Deviation 1.25
|
—
|
SECONDARY outcome
Timeframe: 1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).Population: Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.
Percentage of patients who used rescue medication (by type of rescue medication) in the last year and in the last two years. This percentage was calculated using as denominator the FAS set and was stratified by ICS treatment in the study visit. Data was obtained from medical charts. SABA: Short-acting beta2- agonists \[\*\]: Salbutamol alone, terbutaline alone and salbutamol in combination (IPRATROPIUM BROMIDE /SALBUTAMOL) are included.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients Using Rescue Medication
Last year: R03BB: Anticholinergics
|
9.0 Percentage of participants
|
10.0 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: Use of rescue medication (overall)
|
43.9 Percentage of participants
|
65.7 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: Rescue Medication - SABA
|
35.4 Percentage of participants
|
58.6 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: Rescue Medication - SABA[*] (including salbutamol in combinations)
|
35.4 Percentage of participants
|
58.8 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: Rescue Medication - Others
|
10.0 Percentage of participants
|
12.3 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: R03AC: Selective Beta-2-Adrenoreceptor Agonists
|
35.6 Percentage of participants
|
58.6 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last 2 years: R03BB: Anticholinergics
|
9.2 Percentage of participants
|
10.9 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last year: Use of rescue medication (overall)
|
41.4 Percentage of participants
|
63.9 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last year: Rescue medication - SABA
|
33.0 Percentage of participants
|
56.9 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last year: Rescue medication - SABA[*] (including salbutamol in combinations)
|
33.0 Percentage of participants
|
57.2 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last year: Rescue medication - Others
|
9.6 Percentage of participants
|
11.3 Percentage of participants
|
|
Percentage of Patients Using Rescue Medication
Last year: R03AC: Selective Beta-2-Adrenoreceptor Agonists
|
33.0 Percentage of participants
|
56.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 year prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS with available type of risk and phenotype (n=877).
Number of patients with adherence to treatment recommendations according GesEPOC 2017 guidelines, stratified by risk and phenotypes. Adherence: Patients treated with Inhaled CorticoSteroids (ICS) that according to GesEPOC 2017 should had been treated with ICS; Patients not treated with ICS that according to GesEPOC 2017 should not had been treated with ICS. Non-adherence: Patients treated with ICS but according to GesEPOC 2017 should not have been treated with ICS; Patients not treated with ICS but according to GesEPOC 2017 should have been treated with ICS. Low risk: Patients with Forced Expiratory Volume in 1st second (FEV1) post bronchodilator ≥50% and Modified Medical Research Council (mMRC) (0-1-2) and with ≤1 moderate/severe exacerbation without hospitalization in the last year. High risk: Patients with FEV1 post bronchodilator \<50% or mMRC (3-4) and ≥2 moderate/severe exacerbation or severe ≥1 in the last year. Current phenotype was assigned to high risk patients.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=415 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=462 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
Global · Adherence
|
150 Participants
|
423 Participants
|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
Global · Non-Adherence
|
265 Participants
|
39 Participants
|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
Low Risk · Adherence
|
0 Participants
|
214 Participants
|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
Low Risk · Non-Adherence
|
112 Participants
|
0 Participants
|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
High Risk · Adherence
|
150 Participants
|
209 Participants
|
|
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017
High Risk · Non-Adherence
|
153 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit (1 day).Population: Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.
Percentage of patients with adverse reactions commonly related to Inhaled CorticoSteroids (ICS), which were predefined in the eCRF and per protocol. In this sense, it could be the case of a patient reporting a commonly ICS-related adverse event, without current treatment with ICS at the time of the study visit. Data were obtained from medical charts. Results were reported for COPD patients overall (both arms combined), as the outcome is not related with the current ICS treatment of a patient.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=901 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
Percentage of Patients With ICS-related Adverse Events
|
1.55 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS with available data for this endpoint.
General patient profile for patients treated with inhaled corticosteroid (ICS) and patients not treated with ICS - Body Mass Index (BMI). Weight (in kg) and height (in cm) were collected in the electronic case report form (eCRF). Body Mass Index was calculated (with last measure available): BMI (kg/m\^2) = weight (kg)/ height (m). BMI is categorized into 5 categories according to the World Health Organization (WHO): Underweight: BMI\< 18.5 kg/m\^2; Normal weight: 18.5 kg/m\^2 ≤ BMI ≤ 25 kg/m\^2; Overweight: 25 kg/m\^2\< BMI ≤ 30 kg/m\^2; Obese: 30 kg/m\^2 \< BMI ≤ 35 kg/m\^2; Severely Obese: BMI \> 35 kg/m\^2.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=407 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=446 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Body Mass Index (BMI)
|
28.38 Kg/m^2
Standard Deviation 5.26
|
28.37 Kg/m^2
Standard Deviation 5.11
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS with available data for this endpoint.
General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS. Number of patients by smoking habit (non-smoker, smoker, ex-smoker).
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=430 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Smoking Habit
Non-smoker
|
36 Participants
|
42 Participants
|
|
General Patient Profile - Number of Patients by Smoking Habit
Smoker
|
124 Participants
|
157 Participants
|
|
General Patient Profile - Number of Patients by Smoking Habit
Ex-smoker
|
270 Participants
|
270 Participants
|
SECONDARY outcome
Timeframe: Data collected at study visit.Population: Full Analysis Set (FAS): Patients who provided informed consent and fulfilled all selection criteria.
General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - time since COPD diagnosis. The year of the COPD diagnosis was collected in the electronic case report form (eCRF). The number of years since diagnosis was obtained as the difference between year of study visit and year of COPD diagnosis (+1).
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis
|
10.19 Years
Standard Deviation 6.10
|
8.93 Years
Standard Deviation 5.48
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, auto-calculated at study visit.Population: Patients in the FAS with available data for this endpoint.
General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - Number of patients by GOLD 2019 spirometric classification. GOLD 2019 spirometric classification was auto-calculated according to the information recorded in the eCRF. While the protocol of the study planned to use GOLD 2017 guidelines, guideline updates were expected and it was planned to consider these updates for analysis purposes. For this reason, given that the GOLD 2019 guidelines were updated and effective, this guideline was used for auto-calculation. Spirometric data was collected from clinical records. To determine the severity of all subjects with COPD, patients were categorized into four levels based on their airflow limitation severity (based on post-bronchodilator FEV1 value): Gold 1 (mild): FEV1 (%) ≥ 80% predicted; Gold 2 (Moderate): 50% ≤ FEV1 (%) \< 80% predicted; Gold 3 (Severe): 30% ≤ FEV1 (%) \< 50% predicted; Gold 4 (Very serious): FEV1 (%) \< 30% predicted.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=307 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=326 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
Gold I - Mild
|
57 Participants
|
85 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
Gold II - Moderate
|
164 Participants
|
194 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
Gold III - Severe
|
75 Participants
|
42 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification
Gold IV - Very Severe
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, auto-calculated at study visit.Population: Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.
General patient profile for patients treated with inhaled corticosteroids (ICS) and not treated with ICS - Number of patients by GOLD 2019 patient group (group A, group B, group C, group D). The GOLD 2019 patient group was auto-calculated according the information recorded in the eCRF. According to GOLD 2019 classification, four different types of patient groups were considered regarding their symptom burden and risk of exacerbation (exacerbations, Modified Medical Research Council (mMRC) and COPD Assessment Test (CAT) scores obtained from the eCRF): Group A: 0 or 1 exacerbations (not leading to hospital admission) and mMRC 0-1 and CAT \< 10; Group B: 0 or 1 exacerbations (not leading to hospital admission), and mMRC ≥ 2 or CAT ≥ 10; Group C: ≥ 2 exacerbations or ≥ 1 exacerbation leading to hospital admission, and mMRC 0-1 and CAT \< 10; Group D: ≥2 exacerbations or any ≥ 1 exacerbation leading to hospital admission, and mMRC ≥ 2 or CAT ≥ 10.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
Group A
|
39 Participants
|
54 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
Group B
|
224 Participants
|
330 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
Group C
|
3 Participants
|
6 Participants
|
|
General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups
Group D
|
166 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, auto-calculated at study visit (1 day).Population: Patients in the FAS with available data for this endpoint.
General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - BODEx index. The BODEx index is used to predict the mortality rate from chronic obstructive pulmonary disease (COPD). The BODEx index was auto-calculated according the information recorded in the eCRF. It includes the body mass index (BMI), the degree of dyspnea measured with the mMRC (Modified Medical Research Council) scale, the pulmonary function measured with the FEV1 (%) post-bronchodilation and the number of severe exacerbations (only visits to hospital emergencies and admissions are included). For each item, a score (0-3) is calculated. BODEx index is obtained as the sum of the scores of all items. The index ranges from 0 to 9, with a higher index indicating a higher risk of death.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=297 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=315 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index
|
1.93 Score on a scale
Standard Deviation 1.72
|
1.15 Score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Data measured at study visit.Population: Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.
General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - CAT score. The CAT score was obtained from the sum of 8 items (cough, mucus, chest pressure, dyspnea, limitation in domestic activities, social limitation, sleep, energy). Each item ranging from 0 (no symptoms) to 5 points (highest symptoms). To obtain a valid score, no missing values or missing answers were allowed. The total score was obtained as the sum of the scores of all items, ranging from 0 - 40. The score was grouped into two categories: CAT \<10: Low impact of COPD (Most days are good, the illness prevents the patient from doing one or two things he or she would like, coughing several days a week);CAT ≥10: Medium / high impact of COPD in the patient.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - COPD Assessment Test (CAT) Score
|
16.06 Score on a scale
Standard Deviation 8.03
|
12.96 Score on a scale
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: Data measured at study visit.Population: Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.
General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - mMRC score. The mMRC score was used to assess severity of breathlessness in chronic obstructive pulmonary disease (COPD) patients. Patients were asked to answer the breathlessness scale (Mmrc), a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (grade 0) to almost complete incapacity (grade 4). A lower (higher) grade is considered a better (worse) outcome. Grade 0: None severity Grade 1: Mild severity Grade 2: Moderate severity Grade 3: Severe severity Grade 4: Very severe severity
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Grade 0
|
58 Participants
|
93 Participants
|
|
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Grade 1
|
142 Participants
|
199 Participants
|
|
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Grade 2
|
133 Participants
|
130 Participants
|
|
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Grade 3
|
70 Participants
|
44 Participants
|
|
General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score
Grade 4
|
29 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit (1 day).Population: Patients in the FAS with available data for this endpoint.
General patient profile for patients treated with inhaled corticosteroids (ICS) and patients not treated with ICS - level of eosinophils. Reported is the number of patients by category (low number of eosinophils, high number of eosinophils). Data is obtained from medical charts. Eosinophils were collected in cells per microliter (µl) and the categories are defined as followed: Low number of eosinophils: \< 300 cel/µl; High number of eosinophils: ≥ 300 cel/µl.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=304 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=328 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Level of Eosinophils
Low number of eosinophils
|
208 Participants
|
242 Participants
|
|
General Patient Profile - Number of Patients by Level of Eosinophils
High number of eosinophils
|
96 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: 2 years prior to study visit, data collected at study visit.Population: Full Analysis Set: Patients who provided informed consent and fulfilled all selection criteria.
General patient profile for patients treated with inhaled corticosteroid (ICS) and patients not treated with ICS: Current COPD treatment (treatment patterns for COPD) according to current treatment on ICS. Reported is the number of patients by current COPD treatment. Data is obtained from medical charts. LABA: Long-Acting Beta2-Agonist; LAMA: Long-Acting Muscarinic Antagonist; SABA: Short-acting beta2- agonists; SAMA: Short-acting muscarinic antagonist.
Outcome measures
| Measure |
COPD Patients Treated With ICS at Study Visit
n=432 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
COPD Patients Treated With ICS at Study Visit
n=469 Participants
Patients with chronic obstructive pulmonary disease (COPD) currently (at study visit) treated with Inhaled CorticoSteroids (ICS).
|
|---|---|---|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
Without treatment
|
0 Participants
|
46 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
SABA alone
|
0 Participants
|
6 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
SAMA alone
|
0 Participants
|
5 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
SABA + SAMA
|
0 Participants
|
0 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LABA alone
|
0 Participants
|
3 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LAMA alone
|
0 Participants
|
93 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
ICS alone
|
5 Participants
|
0 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LABA + LAMA
|
0 Participants
|
316 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LABA + ICS
|
106 Participants
|
0 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LAMA + ICS
|
4 Participants
|
0 Participants
|
|
General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment
LABA + LAMA + ICS
|
317 Participants
|
0 Participants
|
Adverse Events
COPD Patients Treated or Not Treated With ICS at Study Visit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place