Clinical trial NCT03003494: Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
Official title: Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 306
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites

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:

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
timeFrame: after approximately 6 weeks
Secondary outcomes:
measure: The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
timeFrame: Baseline (visit 1) and after approx. week 6 (visit 2)
measure: Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2
timeFrame: Baseline (visit 1) and after approx.week 6 (visit 2)
measure: Patient Overall Satisfaction With Spiolto® Respimat®
timeFrame: After approx. 6 weeks of treatment initiation
measure: Patient Satisfaction With Inhaling From the Respimat® Device
timeFrame: After approx. 6 weeks of treatment initiation
measure: Patient Satisfaction With Handling of the Respimat® Inhalation Device
timeFrame: After approx. 6 weeks of treatment initiation
Other outcomes:
Locations:
city: Acquaviva Delle Fonti (BA)
country: Italy
facility: Ospedale Generale Regionale "Miulli"
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
city: Biancavilla
country: Italy
facility: Casa di cura Mons. Calaciura
city: Bussolengo (VR)
country: Italy
facility: Ospedale Orlandi
city: Cassano Murge Bari
country: Italy
facility: IRCCS - Istituto Scientifico di Cassano delle Murge
city: Catanzaro
country: Italy
facility: Università degli Studi "Magna Grecia" - Campus "S. Venuta"
city: Chiari (BS)
country: Italy
facility: Ospedale Mellino Mellini
city: Firenze
country: Italy
facility: Osp. Piero Palagi
city: Foggia
country: Italy
facility: Ospedale Colonnello D Avanzo
city: Garbagnate Milanese
country: Italy
facility: A.O. Ospedale Guido Salvini
city: Imperia
country: Italy
facility: Presidio Ospedaliero di Imperia - ASL 1 Imperiese
city: L'Aquila
country: Italy
facility: Ospedale S. Salvatore
city: LIDO DI Camaiore (LU)
country: Italy
facility: Ospedale della Versilia
city: Mestre
country: Italy
facility: Osp.dell'Angelo
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Osp. dei Colli Monaldi-Cotugno
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Perugia
country: Italy
facility: Ospedale S.Maria della Misericordia, AO di Perugia
city: Pesaro
country: Italy
facility: Azienda Ospedali Riuniti Marche Nord
city: Pordenone
country: Italy
facility: Az.per Assist. Sanitaria N.5 Friuli Occidentale
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
city: Salerno
country: Italy
facility: Università di Salerno
city: Sesto San Giovanni (MI)
country: Italy
facility: Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
city: Tradate (VA)
country: Italy
facility: Fondazione Salvatore Maugeri
city: Trieste
country: Italy
facility: Ospedale di Cattinara
city: Volterra
country: Italy
facility: Auxilium Vitae
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.