Pulmonary Disease, Chronic ObstructiveNCT02675517

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

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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: 1,737 participants
Where: 1 siteGermany
Study dates: 13 Jan 2016to 11 Apr 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: 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 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 LABA/LAMA combination (free and fixed dose) in the previous 6 months
Patients continuing LABA- Inhalative Corticosteroides (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

1 site in 1 country.

Germany1 site

Study site
Multiple Locations

Other trials in Germany

About this study

The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at 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 groups in NCT02675517
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 at Week 6 (Approx.) (Visit 2).
Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Measured: after approximately 6 weeks

Secondary outcomes (5)

Changes in the PF-10 Score From Visit 1 to Visit 2
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).
Measured: baseline and approx. week 6
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.
Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition
Measured: Baseline (Visit 1) and Week 6 (approx.) (Visit 2)
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.
Measured: Week 6 (approx.) (Visit 2)
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.
Measured: Week 6 (approx.) (Visit 2)
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device
Measured: Week 6 (approx.) (Visit 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 201611 Apr 2017

First posted5 Feb 2016 (estimated)
Study start13 Jan 2016
Primary completion10 Mar 2017
Study completion11 Apr 2017

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: 1,737 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02675517
Sponsor's protocol ID: 1237.42
Status last verified: Mar 2018
First submitted: 29 Jan 2016
Last updated: 15 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 28.
PubMed 32857327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2018. 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: NCT02675517
Acronym / sponsor ID: 1237.42
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 1,737 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 13 Jan 2016 (actual)
Primary completion: 10 Mar 2017 (actual)
Study completion: 11 Apr 2017 (actual)
First posted: 5 Feb 2016 (estimated)
Results: Posted 15 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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: COPD patients

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 COPD GOLD guideline recommendation

Key exclusion criteria (7 listed)

Patients with contraindications according to Spiolto® Respimat® SmPC
Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months
Patients continuing LABA- Inhalative Corticosteroides (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 at Week 6 (Approx.) (Visit 2).
Time frame: after approximately 6 weeks
Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.

5 secondary outcomes

Changes in the PF-10 Score From Visit 1 to Visit 2
Time frame: baseline and approx. week 6
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.
Time frame: Baseline (Visit 1) and Week 6 (approx.) (Visit 2)
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).
Time frame: Week 6 (approx.) (Visit 2)
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).
Time frame: Week 6 (approx.) (Visit 2)
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).
Time frame: Week 6 (approx.) (Visit 2)

Results and safety

Results posted to the registry on 15 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiolto Respimat	1,737	1,578

Primary outcome: Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).

Time frame: after approximately 6 weeks. Number (95% Confidence Interval). Unit: Percentage of patients

Measure	Spiolto Respimat n = 1578
Value	51.52 (49.02 to 54.01)

Population analysed: Full analysis set (FAS): This analysis set consist of all screened patients with informed consent, date of registration, at least one documented administration of Spiolto® Respimat® \& available PF-10 score at visit 1\&2, \& confirmed main diagnosis of COPD in whom treatment with long-acting anticholinergics plus bronchodilators is indicated.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until end of study, up to approx 6 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiolto Respimat	3 of 1,737 (0.2%)	0 of 1,737 (0%)	2 of 1,737

Limitations and caveats (from the sponsor): The impact and the interpretation of this Non Interventional Study (NIS) data are limited due to NIS concept

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32857327Taube C, Bayer V, Zehendner CM, Valipour A. Assessment of Patient Experiences with Respimat(R) in Everyday Clinical Practice. Pulm Ther. 2020 Dec;6(2):371-380. doi: 10.1007/s41030-020-00127-4. Epub 2020 Aug 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
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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)
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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.
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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

1 site 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 1 site in Germany.

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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 15 Oct 2018). 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 (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 NCT02675517, 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 15 Oct 2018.