AsthmaNCT02489981
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
An observational study of Asthma, run by Boehringer Ingelheim at 1 site in Brazil.
Trial summary
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials. 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
- How many people
- 359 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2015to 28 Sep 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with severe asthma
Who may be able to join
- Patients diagnosed with severe 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 (Inhaled corticosteroids) 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 this study before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (Patients With Severe Persistent Asthma)
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
- Conditions
- Asthma
- Being tested
- Spiriva
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirivaDrug
60 puffs
| Study group | Role | What they receive |
|---|---|---|
| Spiriva | Patients with severe persistent asthma Receives: Drug: Spiriva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.
Measured: Week 52
Secondary outcomes (1)
Change From Baseline in Asthma Control Status at Week 52
The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on "Asthma prevention and management guideline").
Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52
Measured: Baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Aug 2017
- Study completion28 Sep 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.
- 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
- 359 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
- NCT02489981
- Sponsor's protocol ID
- 205.525
- Status last verified
- Aug 2018
- First submitted
- 21 May 2015
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 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 Severe Persistent Asthma)
- ClinicalTrials.gov ID
- NCT02489981
- Acronym / sponsor ID
- 205.525
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spiriva | – | Drug: SpirivaPatients with severe persistent asthma |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with severe asthma
Key inclusion criteria (3 listed)
- Patients diagnosed with severe 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 (Inhaled corticosteroids) 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 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 |
|---|---|---|
| Spiriva60 puffs | Drug | Spiriva |
Primary outcome
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
Time frame: Week 52
Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.
1 secondary outcome
Change From Baseline in Asthma Control Status at Week 52
Time frame: Baseline and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Asthma, run by Boehringer Ingelheim at 1 site in Brazil.
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 11 Feb 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 Brazil. 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 11 Feb 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 Suspected Adverse Drug Reactions (ADRs) (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2019.