not due to safety reasons

What are the differences between patients prescribed a new maintenance treatment for Chronic Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and clinical characteristics?

Inclusion Criteria:

1. Aged ≥ 40 years at the date of COPD diagnosis.
2. Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis (FEV1/forced vital capacity [FVC] ratio <0.7) and performed within the three years prior to the inclusion visit must be available in the patient's medical records.
3. Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit. The COPD treatment may have been prescribed at primary care sites or at the hospital.
4. Written informed consent prior to participation.

Exclusion Criteria:

1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to or at the index date).

2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD 2019 group at the index date is available in the medical records. Patients may still be included if the determination of the GOLD 2019 group is possible based on the medical records' data and/or patient interviews (e.g. by using information on exacerbation history in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT) at the index date).

2b. For treatment experienced patients - no data on the predominant treatable trait to target at the index date (dyspnea, exacerbation or both) is available in the medical records. Patients may still be included if this information is obtained based on patient interviews.

3. Participation in a clinical trial within the 3 months prior to the inclusion visit.

The source population are COPD patients starting a new maintenance COPD treatment with TIO/OLO or with an ICS-containing regimen in the primary care setting.

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing