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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— OTIVACTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003494
• Other study ID #: 1237.43
• Status: Completed
• Start date: June 6, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Spiolto® Respimat®
observations taken in a period of approximately 6 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

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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