Pulmonary Disease, Chronic ObstructiveNCT02720757
Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO)
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in 6 countries.
Trial summary
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. 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
- 132 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 26 Aug 2016to 14 Dec 2017
- 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: Chronic Obstructive Pulmonary Disease (COPD) patients
Who may be able to join
- Written informed consent prior to participation
- Female and male patients = 40 years of age
- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation
Who cannot join
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with a Long-acting beta2 adrenoceptor agonist\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.
- Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-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 Further exclusion criteria apply
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.
- 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 RespimatDrug
Tiotropium bromide + Olodaterol
| Study group | Role | What they receive |
|---|---|---|
| Spiolto Respimat | COPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 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 After Approximately (Approx.) 6 Weeks After Baseline
"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20.
Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented
Measured: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Secondary outcomes (5)
Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)
Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2.
PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20.
Measured: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)
The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation.
Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.
Measured: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.
Count of patients with divisions from very dissatisfied to very satisfied are presented.
Measured: Visit 2 (approx. 6 weeks post baseline)
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.
Count of patients with divisions from very dissatisfied to very satisfied are presented.
Measured: Visit 2 (approx. 6 weeks post baseline)
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.
Count of patients with divisions from very dissatisfied to very satisfied are presented.
Measured: Visit 2 (approx. 6 weeks post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start26 Aug 2016
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Why it stopped: Recruitment failure
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
- 132 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
- NCT02720757
- Sponsor's protocol ID
- 1237.45
- Status last verified
- Apr 2019
- First submitted
- 3 Mar 2016
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28.
PubMed 34394782
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02720757
- Acronym / sponsor ID
- 1237.45
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2016 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks.
A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to Visit 2 (final visit at the end of the study, approx. 6 weeks after Visit 1), as well as patient satisfaction with Spiolto® Respimat® at Visit 2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spiolto Respimat | – | Drug: Spiolto RespimatCOPD patients requiring a fixed combination therapy of two long-acting bronchodilators (LAMA + LABA) according to approved Summary of Product Characteristics (SmPC) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease (COPD) patients
Key inclusion criteria (3 listed)
- Written informed consent prior to participation
- Female and male patients = 40 years of age
- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and COPD GOLD guideline recommendation
Key exclusion criteria (7 listed)
- Patients with contraindications according to Spiolto® Respimat® SmPC
- Patients who have been treated with a Long-acting beta2 adrenoceptor agonist\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks.
- Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-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 RespimatTiotropium bromide + Olodaterol | Drug | Spiolto Respimat |
Primary outcome
Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
"Therapeutic success" is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented
5 secondary outcomes
Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Time frame: Visit 2 (approx. 6 weeks post baseline)
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Time frame: Visit 2 (approx. 6 weeks post baseline)
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Time frame: Visit 2 (approx. 6 weeks post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34394782Spielmanns M, Tamm M, Schildge S, Valipour A. Swiss Experience in Therapy With Dual Bronchodilation in Chronic Obstructive Pulmonary Disease in Relation to Self-Reported Physical Functionality. J Clin Med Res. 2021 Jul;13(7):392-402. doi: 10.14740/jocmr4542. Epub 2021 Jul 28.
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
6 sites in 6 countries: 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 6 sites in 6 countries.
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: stopped early, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, Luxembourg, Netherlands, Portugal and 1 more country. 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 16 Apr 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 After Approximately (Approx.) 6 Weeks After Baseline (time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)). 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 NCT02720757, 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 16 Apr 2019.