Pulmonary Disease, Chronic Obstructive Clinical Trial
— OTIVACTOOfficial title:
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
NCT number | NCT03003494 |
Other study ID # | 1237.43 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2017 |
Est. completion date | July 30, 2018 |
Verified date | September 2019 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 306 |
Est. completion date | July 30, 2018 |
Est. primary completion date | July 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion criteria: 1. Written informed consent prior to participation 2. Female and male patients = 40 years of age 3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan recommendation Exclusion criteria: 1. Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) 2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months 3. 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 4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. Pregnancy and lactation 6. Patients currently listed for lung transplantation 7. Current participation in any clinical trial or any other non-interventional study of a drug or device |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Generale Regionale "Miulli" | Acquaviva Delle Fonti (BA) | |
Italy | Azienda Ospedaliera G. Rummo | Benevento | |
Italy | Casa di cura Mons. Calaciura | Biancavilla | |
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 | Ospedale Colonnello D Avanzo | Foggia | |
Italy | A.O. Ospedale Guido Salvini | Garbagnate Milanese | |
Italy | Presidio Ospedaliero di Imperia - ASL 1 Imperiese | Imperia | |
Italy | Ospedale S. Salvatore | L'Aquila | |
Italy | Ospedale della Versilia | LIDO DI Camaiore (LU) | |
Italy | Osp.dell'Angelo | Mestre | |
Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | |
Italy | Fondazione Centro San Raffaele del Monte Tabor | 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 | Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza | Roma | |
Italy | Università di Salerno | Salerno | |
Italy | Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano | Sesto San Giovanni (MI) | |
Italy | Fondazione Salvatore Maugeri | Tradate (VA) | |
Italy | Ospedale di Cattinara | Trieste | |
Italy | Auxilium Vitae | Volterra |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | 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. | after approximately 6 weeks | |
Secondary | The Median Change in the PF-10 Score From Visit 1 (Baseline) to 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. | Baseline (visit 1) and after approx. week 6 (visit 2) | |
Secondary | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and 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 | Baseline (visit 1) and after approx.week 6 (visit 2) | |
Secondary | Patient Overall Satisfaction With Spiolto® Respimat® | Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation | |
Secondary | Patient Satisfaction With Inhaling From the Respimat® Device | Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2) | After approx. 6 weeks of treatment initiation | |
Secondary | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2). | After approx. 6 weeks of treatment initiation |
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