Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
- Registration Number
- NCT03003494
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
- Detailed Description
Purpose:
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spiolto® Respimat® Spiolto® Respimat® consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC
- Primary Outcome Measures
Name Time Method Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) after approximately 6 weeks Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome "physical functioning" is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with "yes, limited a lot", "yes, limited a little" or "no, not limited at all", with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with "yes, limited a lot") and 30 (a patient answering all questions with "no, not limited at all"). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.
- Secondary Outcome Measures
Name Time Method Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (visit 1) and after approx.week 6 (visit 2) The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent
The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 Baseline (visit 1) and after approx. week 6 (visit 2) The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.
Patient Overall Satisfaction With Spiolto® Respimat® After approx. 6 weeks of treatment initiation Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).
Patient Satisfaction With Inhaling From the Respimat® Device After approx. 6 weeks of treatment initiation Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)
Patient Satisfaction With Handling of the Respimat® Inhalation Device After approx. 6 weeks of treatment initiation Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).
Trial Locations
- Locations (28)
Ospedale Generale Regionale "Miulli"
🇮🇹Acquaviva Delle Fonti (BA), Italy
Azienda Ospedaliera G. Rummo
🇮🇹Benevento, Italy
Casa di cura Mons. Calaciura
🇮🇹Biancavilla, Italy
Ospedale Colonnello D Avanzo
🇮🇹Foggia, Italy
Presidio Ospedaliero di Imperia - ASL 1 Imperiese
🇮🇹Imperia, Italy
Ospedale S. Salvatore
🇮🇹L'Aquila, Italy
Ospedale Orlandi
🇮🇹Bussolengo (VR), Italy
IRCCS - Istituto Scientifico di Cassano delle Murge
🇮🇹Cassano Murge Bari, Italy
Università degli Studi "Magna Grecia" - Campus "S. Venuta"
🇮🇹Catanzaro, Italy
Ospedale Mellino Mellini
🇮🇹Chiari (BS), Italy
Osp. Piero Palagi
🇮🇹Firenze, Italy
A.O. Ospedale Guido Salvini
🇮🇹Garbagnate Milanese, Italy
Osp.dell'Angelo
🇮🇹Mestre, Italy
Fondazione Centro San Raffaele del Monte Tabor
🇮🇹Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Osp. dei Colli Monaldi-Cotugno
🇮🇹Napoli, Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
🇮🇹Orbassano, Italy
Azienda Ospedaliera Universitaria di Padova
🇮🇹Padova, Italy
Ospedale S.Maria della Misericordia, AO di Perugia
🇮🇹Perugia, Italy
Azienda Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Az.per Assist. Sanitaria N.5 Friuli Occidentale
🇮🇹Pordenone, Italy
Università di Salerno
🇮🇹Salerno, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
🇮🇹Roma, Italy
Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
🇮🇹Sesto San Giovanni (MI), Italy
Ospedale di Cattinara
🇮🇹Trieste, Italy
Auxilium Vitae
🇮🇹Volterra, Italy
Ospedale della Versilia
🇮🇹LIDO DI Camaiore (LU), Italy
Fondazione Salvatore Maugeri
🇮🇹Tradate (VA), Italy