Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.
Detailed description
Study Design:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline. Patients over 40 years old
Exclusion criteria
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma * Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction * Patient with known moderate to severe renal impairment (i.e.,creatinin clearance\<=50ml/min) * Pregnant or nursing women * Patient with any significant disease other than COPD which would exclude him/her from participating in the study * Patients with any conditions listed in \[special precautions\], \[drug interactions\], and \[contraindication\] of Spiriva® China package insert * Patients with signed informed consent of any other study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | 0 weeks (Visit 1) and 8 weeks (Visit 3) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks) |
| Patient Tolerability Assessment at Visit 3 | 8 weeks (Visit 3) | Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | 2 weeks (Visit 2 and 8 weeks (Visit 3) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks) |
| Physician Tolerability Assessment at Visit 3 | 8 weeks (Visit 3) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8) |
Participant flow
Recruitment details
There is a gap between the enrollment number (4922) and the started patients (treatment number, 4812), as some of the enrolled patients did not accept the treatment. the number of started patients was 4918, among which 106 patients prematurely discontinued
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium Bromide | 4,918 |
| Total | 4,918 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | issues not identified by investigators | 18 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Protocol Violation | 57 |
Baseline characteristics
| Characteristic | Tiotropium Bromide |
|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 9.3 |
| Sex/Gender, Customized Female | 1603 participants |
| Sex/Gender, Customized Male | 3313 participants |
| Sex/Gender, Customized Missing information | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,918 |
| serious Total, serious adverse events | 4 / 4,918 |
Outcome results
Primary
Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score good and excellent at visit 1 (0 weeks) and visit 3 (8 weeks)
Time frame: 0 weeks (Visit 1) and 8 weeks (Visit 3)
Population: Sampling Method: Non-Probability Sample; conducted in primary care clinics.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Bromide | Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | Number of patients at visit 1 | 831 Participants |
| Tiotropium Bromide | Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | Number of patients at visit 3 | 4213 Participants |
Comparison: comparing results of post-treatment global assessment by patient with that of pre-treatmentp-value: 0.01Chi-squared
Primary
Patient Tolerability Assessment at Visit 3
Patient tolerability assessment classified as Unsatisfied, Satisfied, Good and Very Good
Time frame: 8 weeks (Visit 3)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Bromide | Patient Tolerability Assessment at Visit 3 | Unsatisfied | 5 Participants |
| Tiotropium Bromide | Patient Tolerability Assessment at Visit 3 | Satisfied | 196 Participants |
| Tiotropium Bromide | Patient Tolerability Assessment at Visit 3 | Good | 1570 Participants |
| Tiotropium Bromide | Patient Tolerability Assessment at Visit 3 | Very Good | 3109 Participants |
Secondary
Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score good and excellent at visit 2 (2 weeks) and visit 3 (8 weeks)
Time frame: 2 weeks (Visit 2 and 8 weeks (Visit 3)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Bromide | Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | Number of patients at visit 2 | 4005 Participants |
| Tiotropium Bromide | Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | Number of patients at visit 3 | 4694 Participants |
Secondary
Physician Tolerability Assessment at Visit 3
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)
Time frame: 8 weeks (Visit 3)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tiotropium Bromide | Physician Tolerability Assessment at Visit 3 | Poor | 2 Participants |
| Tiotropium Bromide | Physician Tolerability Assessment at Visit 3 | Fair | 90 Participants |
| Tiotropium Bromide | Physician Tolerability Assessment at Visit 3 | Good | 1112 Participants |
| Tiotropium Bromide | Physician Tolerability Assessment at Visit 3 | Excellent | 3676 Participants |