N/A
Completed N=901
The OPTI Study in Spain Looks at the History Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Inhaled Steroids.
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03611777 ↗
Enrolled (actual)
901
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: 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
Summary
This non-Interventional, descriptive, cross-sectional cohort and multicentre study will be conducted with COPD patients attended at Spanish Primary Care offices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 | — |
| SECONDARY 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 | — |
| SECONDARY 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 |
46.8; 53.2 | — |
| SECONDARY 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 |
16.6; 83.4; 22.8; 77.2 | — |
| SECONDARY 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 |
0.72; 1.27 | — |
| SECONDARY 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 |
0.26; 0.43 | — |
| SECONDARY Percentage of Patients Using Rescue Medication |
43.9; 65.7; 35.4; 58.6; 35.4; 58.8 | — |
| SECONDARY Number of Patients With Adherence to Treatment Recommendations According Spanish COPD Guidelines (GesEPOC) 2017 |
150; 423; 265; 39; 0; 214 | — |
| SECONDARY Percentage of Patients With ICS-related Adverse Events |
1.55 | — |
| SECONDARY General Patient Profile - Body Mass Index (BMI) |
28.38; 28.37 | — |
| SECONDARY General Patient Profile - Number of Patients by Smoking Habit |
36; 42; 124; 157; 270; 270 | — |
| SECONDARY General Patient Profile - Time Since Chronic Obstructive Pulmonary Disease (COPD) Diagnosis |
10.19; 8.93 | — |
| SECONDARY General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Spirometric Classification |
57; 85; 164; 194; 75; 42 | — |
| SECONDARY General Patient Profile - Number of Patients by Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Patient Groups |
39; 54; 224; 330; 3; 6 | — |
| SECONDARY General Patient Profile - Body Mass Index, Airflow Obstruction, Dyspnea and Exacerbations (BODEx) Index |
1.93; 1.15 | — |
| SECONDARY General Patient Profile - COPD Assessment Test (CAT) Score |
16.06; 12.96 | — |
| SECONDARY General Patient Profile - Number of Patients by Modified Medical Research Council (mMRC) Score |
58; 93; 142; 199; 133; 130 | — |
| SECONDARY General Patient Profile - Number of Patients by Level of Eosinophils |
208; 242; 96; 86 | — |
| SECONDARY General Patient Profile - Number of Patients by Current Chronic Obstructive Pulmonary Disease (COPD) Treatment |
0; 46; 0; 6; 0; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to participation
- Female and male patient ≥ 40 years of age
- Chronic Obstructive Pulmonary Disease (COPD) diagnosis more than 2 years before the study visit
- Previously confirmed Chronic Obstructive Pulmonary Disease (COPD) diagnosis (post-bronchodilator FEV1/FVC ratio <70%)
- Clinical data available 2 years before the study visit
- Ability to complete CAT - COPD Assessment Test
Exclusion Criteria
- Current participation in any clinical trial involving a drug or device
- A moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) during the study visit or within 4 weeks before the study visit
Data sourced from ClinicalTrials.gov (NCT03611777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.