N/A
N=257
OTIVACTO Spain Non Interventional Study
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02927795 ↗Enrolled (actual)
257
Serious AEs
0.4%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) — 66.2 Percentage of Patients (%)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) |
66.2 | — |
| SECONDARY The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 |
16.04 | — |
| SECONDARY Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 |
2; 48; 57; 49; 35; 31 | — |
| SECONDARY Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 |
0; 2; 6; 15; 27; 127 | — |
| SECONDARY Patient Satisfaction With Inhaling From the Respimat® Device |
1; 3; 2; 16; 25; 129 | — |
| SECONDARY Patient Satisfaction With Handling of the Respimat® Inhalation Device |
0; 2; 4; 14; 29; 132 | — |
Summary
This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
Eligibility Criteria
Inclusion criteria
- Written informed consent prior to participation
- Female and male patients = or > 40 years of age
- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation
Exclusion criteria
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
- Patients continuing Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 agonists
- Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks
- Pregnancy and lactation
- Patients currently listed for lung transplantation
- Current participation in any clinical trial or any other non-interventional study of a drug or device
Data sourced from ClinicalTrials.gov (NCT02927795). 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.