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Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Number of patients with AEs | Pre treatment and 52 weeks after the treatment |
| Number of Patients With Adverse Drug Reactions (ADRs) | Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation. | Pre treatment and 52 weeks after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Rate of Comprehensive Evaluation | Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator. Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation". "comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients |
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Inclusion Criteria:
Exclusion Criteria:
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COHORT
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Asahikawa | Japan | ||||
| Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva Treatment | Daily Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 52 weeks |
| Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation | Pre treatment and 52 weeks after the treatment |
| Chikushino-shi |
| Japan |
| Boehringer Ingelheim Investigational Site | Daitō | Japan |
| Boehringer Ingelheim Investigational Site | Ebina | Japan |
| Boehringer Ingelheim Investigational Site | Echizen | Japan |
| Boehringer Ingelheim Investigational Site | Fukui | Japan |
| Boehringer Ingelheim Investigational Site | Fukushima | Japan |
| Boehringer Ingelheim Investigational Site | Funabashi | Japan |
| Boehringer Ingelheim Investigational Site | Gosen | Japan |
| Boehringer Ingelheim Investigational Site | Habikino | Japan |
| Boehringer Ingelheim Investigational Site | Hakodate | Japan |
| Boehringer Ingelheim Investigational Site | Hayashimacho | Japan |
| Boehringer Ingelheim Investigational Site | Higashiosakaka | Japan |
| Boehringer Ingelheim Investigational Site | Himeji | Japan |
| Boehringer Ingelheim Investigational Site | Hirosaki | Japan |
| Boehringer Ingelheim Investigational Site | Hiroshima | Japan |
| Boehringer Ingelheim Investigational Site | Hitachi | Japan |
| Boehringer Ingelheim Investigational Site | Iizuka | Japan |
| Boehringer Ingelheim Investigational Site | Ikoma | Japan |
| Boehringer Ingelheim Investigational Site | Ishinomaki | Japan |
| Boehringer Ingelheim Investigational Site | Itanocho | Japan |
| Boehringer Ingelheim Investigational Site | Kasukabe | Japan |
| Boehringer Ingelheim Investigational Site | Katsuragichō | Japan |
| Boehringer Ingelheim Investigational Site | Kawasaki | Japan |
| Boehringer Ingelheim Investigational Site | Kishiwada | Japan |
| Boehringer Ingelheim Investigational Site | Kitakyushu | Japan |
| Boehringer Ingelheim Investigational Site | Kobayashi | Japan |
| Boehringer Ingelheim Investigational Site | Koga | Japan |
| Boehringer Ingelheim Investigational Site | Komaki | Japan |
| Boehringer Ingelheim Investigational Site | Komatsu | Japan |
| Boehringer Ingelheim Investigational Site | Kōshū | Japan |
| Boehringer Ingelheim Investigational Site | Kumamoto | Japan |
| Boehringer Ingelheim Investigational Site | Kunimichō | Japan |
| Boehringer Ingelheim Investigational Site | Kyoto | Japan |
| Boehringer Ingelheim Investigational Site | Kyōtango | Japan |
| Boehringer Ingelheim Investigational Site | Matsudo | Japan |
| Boehringer Ingelheim Investigational Site | Matsue | Japan |
| Boehringer Ingelheim Investigational Site | Matsumoto | Japan |
| Boehringer Ingelheim Investigational Site | Mihamacho | Japan |
| Boehringer Ingelheim Investigational Site | Minamiuonuma | Japan |
| Boehringer Ingelheim Investigational Site | Mishima | Japan |
| Boehringer Ingelheim Investigational Site | Mizumakimachi | Japan |
| Boehringer Ingelheim Investigational Site | Morioka | Japan |
| Boehringer Ingelheim Investigational Site | Nagaoka | Japan |
| Boehringer Ingelheim Investigational Site | Nagasaki | Japan |
| Boehringer Ingelheim Investigational Site | Nagoya | Japan |
| Boehringer Ingelheim Investigational Site | Nichinan | Japan |
| Boehringer Ingelheim Investigational Site | Niihama | Japan |
| Boehringer Ingelheim Investigational Site | Nōgata | Japan |
| Boehringer Ingelheim Investigational Site | Numata | Japan |
| Boehringer Ingelheim Investigational Site | Obihiro | Japan |
| Boehringer Ingelheim Investigational Site | Odawara | Japan |
| Boehringer Ingelheim Investigational Site | Osaka | Japan |
| Boehringer Ingelheim Investigational Site | Ōbu | Japan |
| Boehringer Ingelheim Investigational Site | Ōgaki | Japan |
| Boehringer Ingelheim Investigational Site | Ōkuchi | Japan |
| Boehringer Ingelheim Investigational Site | Ōtsu | Japan |
| Boehringer Ingelheim Investigational Site | Saiki | Japan |
| Boehringer Ingelheim Investigational Site | Saitama | Japan |
| Boehringer Ingelheim Investigational Site | Sakai | Japan |
| Boehringer Ingelheim Investigational Site | Sakede | Japan |
| Boehringer Ingelheim Investigational Site | Sapporo | Japan |
| Boehringer Ingelheim Investigational Site | Sayama | Japan |
| Boehringer Ingelheim Investigational Site | Sendai | Japan |
| Boehringer Ingelheim Investigational Site | Shiroishi | Japan |
| Boehringer Ingelheim Investigational Site | Shiroishichō | Japan |
| Boehringer Ingelheim Investigational Site | Shizuoka | Japan |
| Boehringer Ingelheim Investigational Site | Tagawa | Japan |
| Boehringer Ingelheim Investigational Site | Takarazuka | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Chiyoda-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Higashiyamato | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Itabashi-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Kita-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Koto-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Meguro-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Otaku-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tokyo Shinjuku-ku | Japan |
| Boehringer Ingelheim Investigational Site | Tsu | Japan |
| Boehringer Ingelheim Investigational Site | Tsukuba | Japan |
| Boehringer Ingelheim Investigational Site | Ube | Japan |
| Boehringer Ingelheim Investigational Site | Uji | Japan |
| Boehringer Ingelheim Investigational Site | Urayasu | Japan |
| Boehringer Ingelheim Investigational Site | Uruma | Japan |
| Boehringer Ingelheim Investigational Site | Utsunomiya | Japan |
| Boehringer Ingelheim Investigational Site | Yamagata | Japan |
| Boehringer Ingelheim Investigational Site | Yame | Japan |
| Boehringer Ingelheim Investigational Site | Yokohama | Japan |
| Boehringer Ingelheim Investigational Site | Yorocho | Japan |
| Boehringer Ingelheim Investigational Site | Yurihonjō | Japan |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Number of participants in this summary is "Number of patients eligible for efficacy analysis"
Throughout this report, the discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva Treatment | Daily Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Effective Rate of Comprehensive Evaluation | Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator. Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation". "comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients | 249 patient were evaluated the efficacy | Posted | Number | percentage of effective patients | 52 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation | All patients for which respiratory function testing was conducted at baseline and at 52 weeks | Posted | Mean | Standard Deviation | Liters | Pre treatment and 52 weeks after the treatment |
|
| ||||||||||||||||||||||||||
| Primary | Number of Patients With Adverse Events (AEs) | Number of patients with AEs | 373 patients were involved in the safety analysis data | Posted | Number | Participants | Pre treatment and 52 weeks after the treatment |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Patients With Adverse Drug Reactions (ADRs) | Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation. | 373 patients were involved in the safety analysis data | Posted | Number | Participants | Pre treatment and 52 weeks after the treatment |
|
|
52 Weeks
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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 Treatment | Daily Therapy | 33 | 373 | 0 | 373 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Lung carcinoma cell type unspecified recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Stupor | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Left atrial dilatation | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Neurogenic bladder | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
|
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Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
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| Unknown |
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| Categories |
|---|
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| Title | Denominators | Categories |
|---|
|