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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiriva Respimat group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiriva Respimat | Drug | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first drug administration until 30 days after last drug administration; up to 337 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with mild to moderate persistent bronchial asthma
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| Name | Affiliation | Role |
|---|---|---|
| Yukako Ogi | zzCDMJP_PV_PMS@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd | Tokyo | 1416017 | Japan |
All participants were screened for eligibility to participate in trial. They attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.
This was a non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) on safety and effectiveness of Spiriva Respimat treatment in patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva Respimat Group | Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients in safety set included patients ≥ 15 years old diagnosed with mild to moderate persistent bronchial asthma who are naive to Spiriva Respimat and received Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least inhaled corticosteroid (ICS) treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva Respimat Group | Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety set | Posted | Count of Participants | Participants | From first drug administration until 30 days after last drug administration; up to 337 days |
|
From first drug administration until 30 days after last drug administration; up to 337 days
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 193 patients were registered and Case Report Forms (CRFs) were collected from 193 patients. The safety set includes 180 patients, excluding 13 patients who had no visit after the first visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spiriva Respimat Group | Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this noninterventional, observational study to collect new real world data (i.e., data under routine medical practice) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2017 | Nov 8, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 19, 2018 | Nov 8, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| baseline and 12 weeks |
| Lost to Follow-up |
|
| Other than specified |
|
| No visit after the first visit |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | 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). | Effectiveness set that excluded patients who were not associated with effectiveness data available (pulmonary function test or laboratory values related to asthma control status) as defined at baseline and/or on treatment. | Posted | Number | participants | baseline and 12 weeks |
|
|
|
| 0 |
| 180 |
| 1 |
| 180 |
| 0 |
| 180 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Title | Measurements |
|---|---|
|
| BL-WC W12-UNK |
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| BL-WC W12-MIS |
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| BL-IC W12-WC |
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| BL-IC W12-IC |
|
| BL-IC W12-PC |
|
| BL-IC W12-UNK |
|
| BL-IC W12-MIS |
|
| BL-PC W12-WC |
|
| BL-PC W12-IC |
|
| BL-PC W12-PC |
|
| BL-PC W12-UNK |
|
| BL-PC W12-MIS |
|
| BL-UNK W12-WC |
|
| BL-UNK W12-IC |
|
| BL-UNK W12-PC |
|
| BL-UNK W12-UNK |
|
| BL-UNK W12-MIS |
|
| BL-MIS W12-WC |
|
| BL-MIS W12-IC |
|
| BL-MIS W12-PC |
|
| BL-MIS W12-UNK |
|
| BL-MIS W12-MIS |
|