Pulmonary Disease, Chronic ObstructiveNIS PIRATENCT05362487

Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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?: Spiriva® Respimat®, Spiriva® HandiHaler® and Tiotropium bromide
Type of treatment: Medical device
How many people: 9 participants
Where: 1 siteSwitzerland
Study dates: 5 Aug 2022to 18 Jan 2023
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: Patients with Chronic Obstructive Pulmonary Disease (COPD) planned to be switched according to the respective Summary of product characteristics (SmPC) and consenting to participate in the study are eligible. To avoid any selection bias, all eligible patients will be invited to participate in this study, in the order in which their eligibility is determined.

Who may be able to join

Participants ≥ 40 years of age at baseline visit
Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
Patients for whom a switch from Spiriva® HandiHaler® to Spiriva® Respimat® was planned prior to study inclusion. If additional inhalative COPD drugs (AICDs) are used: AICD treatment must have been stable for at least 6 weeks before study inclusion
Signed written informed consent form to participation

Who cannot join

Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
Patients with confirmed diagnosis of only asthma
Patients who had > 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion
Patients who are pregnant or breastfeeding
Patients participating in an ongoing interventional study

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal
Liestal, 4410

Other trials in Switzerland

About this study

Official title: Switching COPD Patients From Spiriva® HandiHaler® Maintenance Therapy to Spiriva® Respimat®: a Non-Interventional Real-world clinicAl ouTcome assEssment: NIS PIRATE

The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spiriva® Respimat®, Spiriva® HandiHaler®, Tiotropium bromide
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.

Spiriva® Respimat®Device
Spiriva® Respimat®
Spiriva® HandiHaler®Device
Spiriva® HandiHaler®
Tiotropium bromideDrug
Tiotropium bromide

Study groups in NCT05362487
Study group	Role	What they receive
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®		Not described Receives: Device: Spiriva® Respimat®; Device: Spiriva® HandiHaler®; Drug: Tiotropium bromide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)
Number of participants with 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 in patients with high CCQ baseline score (≥ 2) is reported.
The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).
Measured: Baseline and at Week 8.

Secondary outcomes (5)

Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score
Number of participants with 0.2 points decrease in the CCQ score between baseline and visit 2 in patients independently from CCQ baseline score is reported.
The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).
Measured: Baseline and at Week 8.
Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in All Patients Independently From CCQ Baseline Score
The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values and the CCQ subdomains score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3);very instable-very severe limited (CCQ ≥ 3).
Measured: Baseline and at Week 8.
Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in Patients With High CCQ Baseline Score (≥ 2)
The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values and the CCQ subdomains score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).
Measured: Baseline and at Week 8.
Breathlessness of the Patients at Baseline and at Week 8
This outcome was planned to be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness.
Measured: At baseline and at Week 8.
Changes in Breathlessness of the Patients From Baseline to Week 8
This outcome was planned to be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness.
Measured: At baseline and at Week 8.

Timeline

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

5 Aug 202218 Jan 2023

First posted5 May 2022
Study start5 Aug 2022
Primary completion18 Jan 2023
Study completion18 Jan 2023

Why it stopped: Insufficient recruitment

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.
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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05362487
Sponsor's protocol ID: 0205-0549
Acronym: NIS PIRATE
Status last verified: Feb 2025
First submitted: 2 May 2022
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Switching COPD Patients From Spiriva® HandiHaler® Maintenance Therapy to Spiriva® Respimat®: a Non-Interventional Real-world clinicAl ouTcome assEssment: NIS PIRATE
ClinicalTrials.gov ID: NCT05362487
Acronym / sponsor ID: NIS PIRATE / 0205-0549
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: TerminatedReason stopped: Insufficient recruitment
Enrolment: 9 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 5 Aug 2022 (actual)
Primary completion: 18 Jan 2023 (actual)
Study completion: 18 Jan 2023 (actual)
First posted: 5 May 2022 (actual)
Results: Posted 8 Jul 2024

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
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®	–	Device: Spiriva® Respimat®, Device: Spiriva® HandiHaler®, Drug: Tiotropium bromide

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with Chronic Obstructive Pulmonary Disease (COPD) planned to be switched according to the respective Summary of product characteristics (SmPC) and consenting to participate in the study are eligible. To avoid any selection bias, all eligible patients will be invited to participate in this study, in the order in which their eligibility is determined.

Key inclusion criteria (5 listed)

Participants ≥ 40 years of age at baseline visit
Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
Patients for whom a switch from Spiriva® HandiHaler® to Spiriva® Respimat® was planned prior to study inclusion. If additional inhalative COPD drugs (AICDs) are used: AICD treatment must have been stable for at least 6 weeks before study inclusion
Signed written informed consent form to participation

Key exclusion criteria (7 listed)

Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
Patients with confirmed diagnosis of only asthma
Patients who had > 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion

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
Spiriva® Respimat®Spiriva® Respimat®	Device	Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®
Spiriva® HandiHaler®Spiriva® HandiHaler®	Device	Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®
Tiotropium bromideTiotropium bromide	Drug	Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®

Primary outcome

Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)
Time frame: Baseline and at Week 8.
Number of participants with 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 in patients with high CCQ baseline score (≥ 2) is reported. The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).

5 secondary outcomes

Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score
Time frame: Baseline and at Week 8.
Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in All Patients Independently From CCQ Baseline Score
Time frame: Baseline and at Week 8.
Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in Patients With High CCQ Baseline Score (≥ 2)
Time frame: Baseline and at Week 8.
Breathlessness of the Patients at Baseline and at Week 8
Time frame: At baseline and at Week 8.
Changes in Breathlessness of the Patients From Baseline to Week 8
Time frame: At baseline and at Week 8.

Results and safety

Results posted to the registry on 8 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®	4	0

Primary outcome: Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)

Time frame: Baseline and at Week 8.. Count of participants. Unit: Participants

Measure	Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® n = 3
Value	3

Population analysed: Patients who fulfilled all the eligibility criteria, participated at the baseline visit and had post-baseline data for the primary outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 8 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Switzerland.

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 5 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 26 Feb 2025. 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 Switzerland. 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 8 Jul 2024). 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?

Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2) (time frame: Baseline and at Week 8.). 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 NCT05362487.

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 26 Feb 2025.