N/A
Completed N=4,819
A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03663569 ↗
Enrolled (actual)
4,819
Serious AEs
0.2%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 — 81.38 Percentage of participants
Summary
Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 |
81.38 | — |
| SECONDARY Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 |
1.09; 0.94; 1.04; 1.02 | — |
| SECONDARY Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) |
44; 471; 1176; 1428; 888; 539 | — |
| SECONDARY Physician's Global Evaluation (PGE) Score at Visit 2 |
3; 45; 212; 661; 1227; 1468 | — |
| SECONDARY Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 |
1474; 2055; 803; 236; 64; 44 | — |
| SECONDARY Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 |
1579; 2119; 694; 211; 49; 30 | — |
| SECONDARY Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 |
1554; 2083; 711; 244; 60; 31 | — |
| SECONDARY Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 |
4539; 161 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent prior to participation
- Female and male patients ≥40 years of age
- Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines
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 (NCT03663569). 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.