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Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy

Completed
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
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
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Spiolto® Respimat®Spiolto® Respimat®consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2Baseline (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 2Baseline (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® DeviceAfter 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 DeviceAfter 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

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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

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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

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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

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