Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.
Exclusion criteria
There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | Week 52 | The number of patient with any AEs, patients with drug-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | Week 52 | Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician. |
| Forced Expiratory Volume in One Second (FEV1) | Week 0 and Week 52 | FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated. |
| Cough Frequency | Week 0 and Week 52 | Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently. |
| Shortness of Breath | Week 0 and Week 52 | Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day. |
| Nocturnal Sleep | Week 0 and Week 52 | Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night. |
| Amount of Sputum | Week 0 and Week 52 | Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much. |
Participant flow
Recruitment details
A total of 361 patients were enrolled. Of these patients, the CRF of 4 patients were uncollected by reason of institution, and the 16 patients who did not visit after enrollment. Then, total 341 patients were observed in the survey.
Participants by arm
| Arm | Count |
|---|---|
| Spiriva Respimat Spiriva 2.5 mcg Respimat 60 puffs | 341 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Lost to Follow-up | 28 |
| Overall Study | Other | 18 |
| Overall Study | Withdrawal by Subject | 25 |
Baseline characteristics
| Characteristic | Spiriva Respimat |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 341 |
| serious Total, serious adverse events | 27 / 341 |
Outcome results
Primary
Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with drug-related AEs
Time frame: Week 52
Population: The all treated patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva Respimat | Incidence of Adverse Events (AEs) | patient with any AEs | 53 Patients |
| Spiriva Respimat | Incidence of Adverse Events (AEs) | patients with drug-related AEs | 16 Patients |
Secondary
Amount of Sputum
Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
Time frame: Week 0 and Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiriva Respimat | Amount of Sputum | Week 0 | 2.05 Units on a scale | Standard Deviation 0.74 |
| Spiriva Respimat | Amount of Sputum | Week 52 | 1.63 Units on a scale | Standard Deviation 0.61 |
| Spiriva Respimat | Amount of Sputum | Change from Week 0 to Week 52 | -0.42 Units on a scale | Standard Deviation 0.63 |
Secondary
Cough Frequency
Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
Time frame: Week 0 and Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiriva Respimat | Cough Frequency | Week 0 | 2.10 Units on a scale | Standard Deviation 0.69 |
| Spiriva Respimat | Cough Frequency | Week 52 | 1.62 Units on a scale | Standard Deviation 0.59 |
| Spiriva Respimat | Cough Frequency | Change from Week 0 to Week 52 | -0.47 Units on a scale | Standard Deviation 0.63 |
Secondary
Effectiveness
Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.
Time frame: Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva Respimat | Effectiveness | Improved | 191 Patients |
| Spiriva Respimat | Effectiveness | No change | 122 Patients |
| Spiriva Respimat | Effectiveness | Aggravated | 3 Patients |
Secondary
Forced Expiratory Volume in One Second (FEV1)
FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
Time frame: Week 0 and Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 .
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiriva Respimat | Forced Expiratory Volume in One Second (FEV1) | Week 0 | 1.39 L | Standard Deviation 0.66 |
| Spiriva Respimat | Forced Expiratory Volume in One Second (FEV1) | Week 52 | 1.46 L | Standard Deviation 0.66 |
| Spiriva Respimat | Forced Expiratory Volume in One Second (FEV1) | Change from Week 0 to Week 52 | 0.06 L | Standard Deviation 0.28 |
Secondary
Nocturnal Sleep
Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.
Time frame: Week 0 and Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiriva Respimat | Nocturnal Sleep | Week 0 | 1.55 Units on a scale | Standard Deviation 0.84 |
| Spiriva Respimat | Nocturnal Sleep | Week 52 | 1.25 Units on a scale | Standard Deviation 0.6 |
| Spiriva Respimat | Nocturnal Sleep | Change from Week 0 to Week 52 | -0.31 Units on a scale | Standard Deviation 0.58 |
Secondary
Shortness of Breath
Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.
Time frame: Week 0 and Week 52
Population: The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiriva Respimat | Shortness of Breath | Week 0 | 3.28 Units on a scale | Standard Deviation 1.29 |
| Spiriva Respimat | Shortness of Breath | Week 52 | 2.69 Units on a scale | Standard Deviation 1.34 |
| Spiriva Respimat | Shortness of Breath | Change from Week 0 to Week 52 | -0.59 Units on a scale | Standard Deviation 0.82 |