N/A
N=1,351
Changes in Health and Functional Status in Patients With Chronic Obstructive Pulmonary Disease During Therapy With Spiolto® Respimat® (AERIAL®)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03165045 ↗Enrolled (actual)
1,351
Serious AEs
0.1%
Results posted
Apr 2020
Primary outcome: Primary: Therapeutic Success — 756 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Spiolto® Respimat® (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Success |
756 | — |
| SECONDARY Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 |
0.84; 0.75; 0.73; 0.78 | — |
| SECONDARY General Condition of the Patient |
11; 1; 93; 23; 281; 95 | — |
| SECONDARY Patient Satisfaction With Spiolto® Respimat® at Visit 2 |
427; 544; 95; 46; 13; 12 | — |
| SECONDARY Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 |
1194 | — |
Summary
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
Eligibility Criteria
Inclusion Criteria
Patients can be included if all of the following criteria are met:
- Written informed consent prior to participation
- Female and male patients ≥40 years of age
- Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D)
- Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.
Exclusion Criteria
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry
- Patients continuing LABA-ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists
- Pregnancy and lactation
- Current participation in any clinical trial or any other non-interventional study of a drug or device.
Data sourced from ClinicalTrials.gov (NCT03165045). 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.