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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiriva | Patients with severe persistent asthma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiriva | Drug | 60 puffs |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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patients with severe asthma
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital FelÃcio Rocho | Belo Horizonte | 30110-060 | Brazil |
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
The objective of this Post Marketing Surveillance (PMS) was to investigate the safety and effectiveness of Spiriva Respimat in patients with severe persistent asthma under real-world use. This is a regulatory required PMS to investigate the safety and effectiveness of Spiriva® 2.5 μg Respimat® 60 puffs in patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva® Respimat® | Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiriva Respimat except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva® Respimat® | Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of signing informed consent form is presented. |
| 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 | 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. | Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiriva Respimat except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact. | Posted | Number | Percentage of participants | Week 52 |
|
From first drug administration until 30 days after last drug administration.
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 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
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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® | Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA 20.0 | 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 Centre | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2017 | Aug 30, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 22, 2015 | Aug 30, 2018 | Prot_001.pdf |
| 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 Week 52 |
| Lost to Follow-up |
|
| Other than listed |
|
SafetySet
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Number of subjects is categorized as Male or Female. | Safety Set | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Efficacy set: This patient set is a subset of the safety set that includes all patients in the safety set who have baseline and at least one available on-treatment asthma control status, Peak Expiratory Flow Rate (PEFR), Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) or Asthma Control Questionnaire (ACQ) 6 score. | Posted | Number | Percentage of participants | Baseline and Week 52 |
|
|
|
| 1 |
| 340 |
| 10 |
| 340 |
| 0 |
| 340 |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
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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 |
|
| PC_BL & WC_52 |
|
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| Unk_BL & WC_52 |
|
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| Miss_BL & WC_52 |
|
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| WC_BL & IC_52 |
|
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| IC_BL & IC_52 |
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| PC_BL & IC_52 |
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| Unk_BL & IC_52 |
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| Miss_BL & IC_52 |
|
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| WC_BL & PC_52 |
|
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| IC_BL & PC_52 |
|
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| PC_BL & PC_52 |
|
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| Unk_BL & PC_52 |
|
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| Miss_BL & PC_52 |
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| WC_BL & Unk_52 |
|
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| IC_BL & Unk_52 |
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| PC_BL & Unk_52 |
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| Unk_BL & Unk_52 |
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| Miss_BL & Unk_52 |
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| WC_BL & Miss_52 |
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| IC_BL & Miss_52 |
|
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| PC_BL & Miss_52 |
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| Unk_BL & Miss_52 |
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| Miss_BL & Miss_52 |
|
|