Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
OTIVACTO
1 other identifier
observational
306
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedResults Posted
Study results publicly available
September 30, 2019
CompletedSeptember 30, 2019
September 1, 2019
1.1 years
December 22, 2016
July 29, 2019
September 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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)
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)
Patient Overall Satisfaction With Spiolto® Respimat®
After approx. 6 weeks of treatment initiation
Patient Satisfaction With Inhaling From the Respimat® Device
After approx. 6 weeks of treatment initiation
Patient Satisfaction With Handling of the Respimat® Inhalation Device
After approx. 6 weeks of treatment initiation
Study Arms (1)
Spiolto® Respimat®
consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC
Interventions
observations taken in a period of approximately 6 weeks
Eligibility Criteria
400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites
You may qualify if:
- Written informed consent prior to participation
- Female and male patients = 40 years of age
- Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan recommendation
You may not qualify if:
- Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Ospedale Generale Regionale "Miulli"
Acquaviva Delle Fonti (BA), 70021, Italy
Azienda Ospedaliera G. Rummo
Benevento, 82100, Italy
Casa di cura Mons. Calaciura
Biancavilla, 95033, Italy
Ospedale Orlandi
Bussolengo (VR), 37012, Italy
IRCCS - Istituto Scientifico di Cassano delle Murge
Cassano Murge Bari, 70020, Italy
Università degli Studi "Magna Grecia" - Campus "S. Venuta"
Catanzaro, 88100, Italy
Ospedale Mellino Mellini
Chiari (BS), Italy
Osp. Piero Palagi
Florence, 50125, Italy
Ospedale Colonnello D Avanzo
Foggia, 71100, Italy
A.O. Ospedale Guido Salvini
Garbagnate Milanese, 20090, Italy
Presidio Ospedaliero di Imperia - ASL 1 Imperiese
Imperia, 18100, Italy
Ospedale della Versilia
LIDO DI Camaiore (LU), 55043, Italy
Ospedale S. Salvatore
L’Aquila, Italy
Osp.dell'Angelo
Mestre, 30171, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Osp. dei Colli Monaldi-Cotugno
Napoli, 80131, Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedaliera Universitaria di Padova
Padua, 35128, Italy
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, 06156, Italy
Azienda Ospedali Riuniti Marche Nord
Pesaro, 61100, Italy
Az.per Assist. Sanitaria N.5 Friuli Occidentale
Pordenone, 33170, Italy
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189, Italy
Università di Salerno
Salerno, 84121, Italy
Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
Sesto San Giovanni (MI), 20099, Italy
Fondazione Salvatore Maugeri
Tradate (VA), 21049, Italy
Ospedale di Cattinara
Trieste, 34149, Italy
Auxilium Vitae
Volterra, 56048, Italy
Related Publications (1)
Carone M, Pennisi A, D'Amato M, Donati AF, Ricci A, Scognamillo C, Chun L, Aliani M, Ronsivalle V, Pelaia G. Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease Treated with Tiotropium/Olodaterol Respimat in Routine Clinical Practice in Italy. Pulm Ther. 2020 Dec;6(2):261-274. doi: 10.1007/s41030-020-00122-9. Epub 2020 Jun 18.
PMID: 32557394DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Therapeutic success was assessed by a patient questionnaire at two time points. The respective answers were dependent on the condition of the patient at the completion. No objective assessment was performed due to the non-interventional study concept
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
December 28, 2016
Study Start
June 6, 2017
Primary Completion
July 30, 2018
Study Completion
July 30, 2018
Last Updated
September 30, 2019
Results First Posted
September 30, 2019
Record last verified: 2019-09