N/A
Completed N=7,443
OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02719639 ↗
Enrolled (actual)
7,443
Serious AEs
0.1%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Patients With Therapeutic Success After Approximately 6 Weeks. — 67.76 Percentage of participants (%)
Summary
Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Therapeutic Success After Approximately 6 Weeks. |
67.76 | — |
| SECONDARY Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) |
16.62 | — |
| SECONDARY General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). |
96; 754; 1907; 2159; 1317; 743 | — |
| SECONDARY Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) |
2847; 2998; 890; 307; 93; 52 | — |
| SECONDARY Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) |
3143; 3021; 716; 228; 48; 34 | — |
| SECONDARY Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) |
3086; 2988; 794; 239; 55; 30 | — |
Eligibility Criteria
Inclusion criteria
- Written informed consent prior to participation
- Female and male patients with more or equal to 40 years of age
- Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (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 LABA- Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto Respimat in order to avoid a double dosing of long-acting beta-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 (NCT02719639). 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.