AsthmaNCT03188120

Specific Use-Result of Spiriva Respimat® in Asthmatics

An observational study of Asthma, run by Boehringer Ingelheim at 1 site in Japan.

Completed

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

Trial summary

The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Asthma
What is being tested?: Spiriva Respimat
How many people: 193 participants
Where: 1 siteJapan
Study dates: 4 Jul 2017to 8 Nov 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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients diagnosed with mild to moderate persistent bronchial asthma

Who may be able to join

Patients diagnosed with mild to moderate persistent bronchial asthma
Patient aged ≥ 15 years
Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.

Who cannot join

Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
Patients who have been enrolled in this study before.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd
Tokyo, 1416017

Other trials in Japan

About this study

Official title: Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)

The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Read the detailed description

The study is Post-Marketing Surveillance on the Long-Term Use of Spiriva Respimat in Japanese patients with mild to moderate persistent asthma. The patient population who receive Spiriva Respimat and the safety profile is not expected to change. This study can investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Conditions: Asthma
Being tested: Spiriva Respimat
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spiriva RespimatDrug
Also called FORVENT, SPIRIVA, SRIVASSO
Drug

Study groups in NCT03188120
Study group	Role	What they receive
Spiriva Respimat group		Not described Receives: Drug: Spiriva Respimat

What is being measured

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

Number of Participants With Suspected Adverse Drug Reactions (ADRs)
Number of participants with suspected adverse drug reactions (ADRs) is presented.
An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.
Measured: From first drug administration until 30 days after last drug administration; up to 337 days

Secondary outcomes (1)

The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline
The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented.
Well controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes.
Abbreviations used:
Baseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as "no change". If a patient insufficiently controlled or poorly controlled at baseline became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as "effective" (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as "ineffective" (or the patient assessed as a non-responder).
Measured: baseline and 12 weeks

Timeline

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

4 Jul 20178 Nov 2018

First posted15 Jun 2017
Study start4 Jul 2017
Primary completion22 Sep 2018
Study completion8 Nov 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.
Other trials for AsthmaStudies 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: 193 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03188120
Sponsor's protocol ID: 0205-0536
Status last verified: Nov 2019
First submitted: 13 Jun 2017
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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 Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Specific Use-Result Surveillance of Spiriva Respimat in Asthmatics (Patients With Mild and Moderate Persistent Asthma)
ClinicalTrials.gov ID: NCT03188120
Acronym / sponsor ID: 0205-0536
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 193 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 4 Jul 2017 (actual)
Primary completion: 22 Sep 2018 (actual)
Study completion: 8 Nov 2018 (actual)
First posted: 15 Jun 2017 (actual)
Results: Posted 27 Nov 2019

Clinical summary

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

The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Spiriva Respimat group	–	Drug: Spiriva Respimat

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients diagnosed with mild to moderate persistent bronchial asthma

Key inclusion criteria (3 listed)

Patients diagnosed with mild to moderate persistent bronchial asthma
Patient aged ≥ 15 years
Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS treatment.

Key exclusion criteria (2 listed)

Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat
Patients who have been enrolled in this study before.

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 RespimatAlso: FORVENT, SPIRIVA, SRIVASSODrug	Drug	Spiriva Respimat group

Primary outcome

Number of Participants With Suspected Adverse Drug Reactions (ADRs)
Time frame: From first drug administration until 30 days after last drug administration; up to 337 days
Number of participants with suspected adverse drug reactions (ADRs) is presented. An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.

1 secondary outcome

The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline
Time frame: baseline and 12 weeks

Results and safety

Results posted to the registry on 27 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiriva Respimat Group	193	146

Primary outcome: Number of Participants With Suspected Adverse Drug Reactions (ADRs)

Time frame: From first drug administration until 30 days after last drug administration; up to 337 days. Count of participants. Unit: Participants

Measure	Spiriva Respimat Group n = 180
Value	5

Population analysed: Safety set

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first drug administration until 30 days after last drug administration; up to 337 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva Respimat Group	1 of 180 (0.6%)	0 of 180 (0%)	0 of 180

Limitations and caveats (from the sponsor): Patients were not randomized and there are no within-study data. Patients in the study may differ from the overall asthma-treated population, or from treated patients who did not choose to participate in the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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Community Acquired Pneumonia (CAP)
RecruitingPhase 2
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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.

Yukako Ogi study chair

zzCDMJP_PV_PMS@boehringer-ingelheim.com

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 Asthma, run by Boehringer Ingelheim at 1 site in Japan.

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 2 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 27 Nov 2019. 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 Japan. 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 27 Nov 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?

Number of Participants With Suspected Adverse Drug Reactions (ADRs) (time frame: From first drug administration until 30 days after last drug administration; up to 337 days). 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 NCT03188120.

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 27 Nov 2019.