A Phase IV Real-World Multi-Country Observational Study on Patients' Disease Control and Self-Reported Outcomes During Fixed Dose Combination Inhaler Treatment for Persistent Asthma and COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,743
- Locations
- 141
- Primary Endpoint
- Percentage of patients whose respiratory disease is well controlled
Study Overview
Brief Summary
The study is to evaluate the percentage of patients with asthma or COPD achieving disease control
Detailed Description
There are no treatment groups or interventions to which the patients can be randomly assigned. Data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. Participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. All treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with COPD
- •Treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a Inhaled corticosteroid (ICS), Long-acting beta2-agonists (LABA), Fixed dose combination (FDC) administered twice daily by Dry powder inhaler (DPI) for 3 months prior to enrollment in accordance with its approved indication
- •Patient is willing and able to provide written informed consent;
- •Patient agrees to participate in the study and to disclose any medical events to the treating physician;
- •Patient is able to complete the questionnaires.
Exclusion Criteria
- •Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).
Arms & Interventions
Patient Participants
Patients are confirmed to have either Persistent Asthma or COPD
Intervention: Marketed antagonists (Drug)
Outcomes
Primary Outcomes
Percentage of patients whose respiratory disease is well controlled
Time Frame: 1 Day
Questionnaires capture descriptive, qualitative responses
Secondary Outcomes
- Most Important Inhaler Features (MIIF) questionnaire(1 Day)
- Patient Satisfaction Score(1 Day)
- Percentage of Participants with Adverse Events(3 years)
- Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)(1 Day)