40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Did Not Have Moderate or Severe Exacerbation in the Year Prior to the Study VisitPrimary· 1 year prior to study visit, data collected at study visit (1 day).
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
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
62.5
57.8 – 67.0
Percentage of Patients Currently on Inhaled CorticoSteroids (ICS) Who Have Had Moderate or Severe Exacerbation in the Year Prior to the Study VisitSecondary· 1 year prior to study visit, data collected at study visit (1 day).
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 anti
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
37.5
32.9 – 42.3
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 VisitSecondary· 2 years prior to study visit, data collected at study visit (1 day).
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 t
With moderate or severe exacerbations
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
46.8
Without moderate or severe exacerbations
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
53.2
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 VisitSecondary· 1 year and 2 years prior to study visit, data collected at study visit (1 day).
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
1 year prior study visit: With moderate or severe exacerbations
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
16.6
1 year prior study visit: Without moderate or severe exacerbations
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
83.4
2 years prior study visit: With moderate or severe exacerbation
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
22.8
2 years prior study visit: Without moderate or severe exacerbations
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
77.2
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 VisitSecondary· 1 year and 2 years prior to study visit, data collected 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 s
1 year prior study visit
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
0.72
± 1.23
2 years prior to study visit
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
1.27
± 1.99
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 VisitSecondary· 1 year and 2 years prior to study visit, data collected 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 wit
1 year prior study visit
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
0.26
± 0.77
2 years prior study visit
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
0.43
± 1.25
Percentage of Patients Using Rescue MedicationSecondary· 1 year (last year) and 2 years (last 2 years) prior to study visit, data was collected at study visit (1 day).
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.
Last 2 years: Use of rescue medication (overall)
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
43.9
COPD Patients Treated With ICS at Study Visit
65.7
Last 2 years: Rescue Medication - SABA
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
35.4
COPD Patients Treated With ICS at Study Visit
58.6
Last 2 years: Rescue Medication - SABA[*] (including salbutamol in combinations)
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
35.4
COPD Patients Treated With ICS at Study Visit
58.8
Last 2 years: Rescue Medication - Others
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
10.0
COPD Patients Treated With ICS at Study Visit
12.3
Last 2 years: R03AC: Selective Beta-2-Adrenoreceptor Agonists
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
35.6
COPD Patients Treated With ICS at Study Visit
58.6
Last 2 years: R03BB: Anticholinergics
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
9.2
COPD Patients Treated With ICS at Study Visit
10.9
Last year: Use of rescue medication (overall)
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
41.4
COPD Patients Treated With ICS at Study Visit
63.9
Last year: Rescue medication - SABA
Group
Value
95% CI
COPD Patients Not Treated With ICS at Study Visit
33.0
COPD Patients Treated With ICS at Study Visit
56.9
Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017Secondary· 1 year prior to study visit, data collected at study visit (1 day).
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 E
Global
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
150
COPD Patients Not Treated With ICS at Study Visit
423
COPD Patients Treated With ICS at Study Visit
265
COPD Patients Not Treated With ICS at Study Visit
39
Low Risk
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
0
COPD Patients Not Treated With ICS at Study Visit
214
COPD Patients Treated With ICS at Study Visit
112
COPD Patients Not Treated With ICS at Study Visit
0
High Risk
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
150
COPD Patients Not Treated With ICS at Study Visit
209
COPD Patients Treated With ICS at Study Visit
153
COPD Patients Not Treated With ICS at Study Visit
39
Percentage of Patients With ICS-related Adverse EventsSecondary· 2 years prior to study visit, data collected at study visit (1 day).
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.
Group
Value
95% CI
Patients With COPD - Overall
1.55
General Patient Profile - Body Mass Index (BMI)Secondary· 2 years prior to study visit, data collected at study visit (1 day).
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:
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
28.38
± 5.26
COPD Patients Not Treated With ICS at Study Visit
28.37
± 5.11
General Patient Profile - Number of Patients by Smoking HabitSecondary· 2 years prior to study visit, data collected at study visit (1 day).
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).
Non-smoker
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
36
COPD Patients Not Treated With ICS at Study Visit
42
Smoker
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
124
COPD Patients Not Treated With ICS at Study Visit
157
Ex-smoker
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
270
COPD Patients Not Treated With ICS at Study Visit
270
General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) DiagnosisSecondary· Data collected at study visit.
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).
Group
Value
95% CI
COPD Patients Treated With ICS at Study Visit
10.19
± 6.10
COPD Patients Not Treated With ICS at Study Visit
8.93
± 5.48
Sponsor's own description
This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 8 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03611777.