Pulmonary Disease, Chronic ObstructiveOTIVACTONCT03003494
Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 28 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Spiolto® Respimat®
- How many people
- 306 participants
- Where
- 28 sitesItaly
- Study dates
- 6 Jun 2017to 30 Jul 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites
Ospedale Generale Regionale "Miulli"
Acquaviva Delle Fonti (BA), 70021
Azienda Ospedaliera G. Rummo
Benevento, 82100
Casa di cura Mons. Calaciura
Biancavilla, 95033
Ospedale Orlandi
Bussolengo (VR), 37012
IRCCS - Istituto Scientifico di Cassano delle Murge
Cassano Murge Bari, 70020
Università degli Studi "Magna Grecia" - Campus "S. Venuta"
Catanzaro, 88100
Ospedale Mellino Mellini
Chiari (BS)
Osp. Piero Palagi
Florence, 50125
Ospedale Colonnello D Avanzo
Foggia, 71100
A.O. Ospedale Guido Salvini
Garbagnate Milanese, 20090
Presidio Ospedaliero di Imperia - ASL 1 Imperiese
Imperia, 18100
Ospedale S. Salvatore
L’Aquila
Ospedale della Versilia
LIDO DI Camaiore (LU), 55043
Osp.dell'Angelo
Mestre, 30171
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Osp. dei Colli Monaldi-Cotugno
Naples, 80131
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano, 10043
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, 06156
Azienda Ospedali Riuniti Marche Nord
Pesaro, 61100
Az.per Assist. Sanitaria N.5 Friuli Occidentale
Pordenone, 33170
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189
Università di Salerno
Salerno, 84121
Presidio Ospedaliero di Sesto S. Giovanni ASST Nord Milano
Sesto San Giovanni (MI), 20099
Fondazione Salvatore Maugeri
Tradate (VA), 21049
Ospedale di Cattinara
Trieste, 34149
Auxilium Vitae
Volterra, 56048
About this study
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.
Read the detailed description
Purpose:
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Spiolto® Respimat®
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiolto® Respimat®Drug
Also called INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
observations taken in a period of approximately 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Spiolto® Respimat® | consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC Receives: Drug: Spiolto® Respimat® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after approximately 6 weeks
Secondary outcomes (5)
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.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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).
Measured: After approx. 6 weeks of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start6 Jun 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003494
- Sponsor's protocol ID
- 1237.43
- Acronym
- OTIVACTO
- Status last verified
- Sep 2019
- First submitted
- 22 Dec 2016
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32557394
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy
- ClinicalTrials.gov ID
- NCT03003494
- Acronym / sponsor ID
- OTIVACTO / 1237.43
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spiolto® Respimat® | – | Drug: Spiolto® Respimat®consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 400 chronic obstructive pulmonary disease (COPD) patients will be enrolled in Pulmonology sites
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiolto® Respimat®Also: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMOobservations taken in a period of approximately 6 weeks | Drug | Spiolto® Respimat® |
Primary outcome
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
Time frame: after approximately 6 weeks
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.
5 secondary outcomes
The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
Time frame: 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
Time frame: Baseline (visit 1) and after approx.week 6 (visit 2)
Patient Overall Satisfaction With Spiolto® Respimat®
Time frame: After approx. 6 weeks of treatment initiation
Patient Satisfaction With Inhaling From the Respimat® Device
Time frame: After approx. 6 weeks of treatment initiation
Patient Satisfaction With Handling of the Respimat® Inhalation Device
Time frame: After approx. 6 weeks of treatment initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32557394Carone 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) (time frame: after approximately 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.