Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients of Chronic Obstructive Pulmonary Disease 2. Patients were expected to use the product for long period of time
Exclusion criteria
1. Patients with glaucoma 2. Patients with micturition disorder due to prostatic hyperplasia etc. 3. Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Pre treatment and 52 weeks after the treatment | Number of patients with AEs |
| Number of Patients With Adverse Drug Reactions (ADRs) | Pre treatment and 52 weeks after the treatment | Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective Rate of Comprehensive Evaluation | 52 weeks | 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 |
| Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | Pre treatment and 52 weeks after the treatment | 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spiriva Treatment Daily Therapy | 249 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 23 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 46 |
| Overall Study | Other reason not defined above | 27 |
| Overall Study | Physician Decision | 9 |
Baseline characteristics
| Characteristic | Spiriva Treatment |
|---|---|
| Age, Customized 65≤ to <75 years | 88 Participants |
| Age, Customized <65 years | 51 Participants |
| Age, Customized >=75 years | 103 Participants |
| Age, Customized Unknown | 7 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 212 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 373 |
| serious Total, serious adverse events | 33 / 373 |
Outcome results
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.
Time frame: Pre treatment and 52 weeks after the treatment
Population: 373 patients were involved in the safety analysis data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva Treatment | Number of Patients With Adverse Drug Reactions (ADRs) | 27 Participants |
Primary
Number of Patients With Adverse Events (AEs)
Number of patients with AEs
Time frame: Pre treatment and 52 weeks after the treatment
Population: 373 patients were involved in the safety analysis data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva Treatment | Number of Patients With Adverse Events (AEs) | 71 Participants |
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
Time frame: Pre treatment and 52 weeks after the treatment
Population: All patients for which respiratory function testing was conducted at baseline and at 52 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva Treatment | Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | 0.119 Liters | Standard Deviation 0.208 |
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
Time frame: 52 weeks
Population: 249 patient were evaluated the efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva Treatment | Effective Rate of Comprehensive Evaluation | 70.9 percentage of effective patients |