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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Spiolto® Respimat®

Detailed Description

Purpose:

• Study Type: Observational
• Enrollment (Actual): 306

Contacts and Locations

Study Locations

• Italy
  • Acquaviva Delle Fonti (BA), Italy, 70021
    • Ospedale generale regionale "Miulli"
  • Benevento, Italy, 82100
    • Azienda Ospedaliera G. Rummo
  • Biancavilla, Italy, 95033
    • Casa di cura Mons. Calaciura
  • Bussolengo (VR), Italy, 37012
    • Ospedale Orlandi
  • Cassano Murge Bari, Italy, 70020
    • IRCCS - Istituto Scientifico di Cassano delle Murge
  • Catanzaro, Italy, 88100
    • Università degli Studi "Magna Grecia" - Campus "S. Venuta"
  • Chiari (BS), Italy
    • Ospedale Mellino Mellini
  • Firenze, Italy, 50125
    • Osp. Piero Palagi
  • Foggia, Italy, 71100
    • Ospedale Colonnello D Avanzo
  • Garbagnate Milanese, Italy, 20090
    • A.O. Ospedale Guido Salvini
  • Imperia, Italy, 18100
    • Presidio Ospedaliero di Imperia - ASL 1 Imperiese
  • L'Aquila, Italy
    • Ospedale S. Salvatore
  • LIDO DI Camaiore (LU), Italy, 55043
    • Ospedale della Versilia
  • Mestre, Italy, 30171
    • Osp.dell'Angelo
  • Milano, Italy, 20132
    • Fondazione Centro San Raffaele del Monte Tabor
  • Milano, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Napoli, Italy, 80131
    • Osp. dei Colli Monaldi-Cotugno
  • Orbassano, Italy, 10043
    • Azienda Sanitaria Ospedale S. Luigi Gonzaga
  • Padova, Italy, 35128
    • Azienda Ospedaliera Universitaria di Padova
  • Perugia, Italy, 06156
    • Ospedale S.Maria della Misericordia, AO di Perugia
  • Pesaro, Italy, 61100
    • Azienda Ospedali Riuniti Marche Nord
  • Pordenone, Italy, 33170
    • Az.per Assist. Sanitaria N.5 Friuli Occidentale
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
  • Salerno, Italy, 84121
    • Università di Salerno
  • Sesto San Giovanni (MI), Italy, 20099
    • Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
  • Tradate (VA), Italy, 21049
    • Fondazione Salvatore Maugeri
  • Trieste, Italy, 34149
    • Ospedale di Cattinara
  • Volterra, Italy, 56048
    • Auxilium Vitae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spiolto® Respimat®; consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC	Drug: Spiolto® Respimat®; observations taken in a period of approximately 6 weeks; Other Names: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1237.43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No