Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central & Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.
Detailed description
Study Design: an open-label, uncontrolled and single arm post-marketing surveillance study
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
* 40 years and older male and female ambulatory outpatients. * Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) \< 0.7 and FEV1 \< 80% predicted). * Stable patient, without exacerbation for at least one month to the study.
Exclusion criteria
* Uncooperative patients as judged by the physician. * Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study. * Patients with any conditions excluded as per Country specific package insert. * Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline | Baseline and 6 months | The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Bronchodilator or Inhaled Corticosteroids (ICS) | 6 months | Pulmonary medication from baseline to visit 3 (6 months) |
| Compliance of Patients | 6 months | Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10. |
| Patients With Any Adverse Events | 6 months | — |
Countries
Croatia, Poland, Romania, Russia, Slovakia, Slovenia
Participant flow
Pre-assignment details
Whilst 4854 patients were enrolled in the study, only 4852 of these entered and were included in the treated set, since two patients had no evidence of Spiriva administration.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With Spiriva Treatment with 18 mcg tiotropium inhalation capsules of Spiriva | 4,852 |
| Total | 4,852 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Lost to Follow-up | 32 |
| Overall Study | Other | 72 |
| Overall Study | Protocol Violation | 14 |
Baseline characteristics
| Characteristic | Patients Treated With Spiriva |
|---|---|
| Age, Continuous | 62.6 Years STANDARD_DEVIATION 9.8 |
| Sex/Gender, Customized Female | 1391 Participants |
| Sex/Gender, Customized Male | 3433 Participants |
| Sex/Gender, Customized Missing | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4,852 |
| serious Total, serious adverse events | 15 / 4,852 |
Outcome results
Primary
Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline
The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Time frame: Baseline and 6 months
Population: Patients from the treated set (TS) who have evaluable SGRQ measurements at baseline and Visit 3 (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With Spiriva | Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline | -21.73 Units on a scale | Standard Deviation 19.09 |
Secondary
Additional Bronchodilator or Inhaled Corticosteroids (ICS)
Pulmonary medication from baseline to visit 3 (6 months)
Time frame: 6 months
Population: Patients from Full Analysis Set (FAS) which includes all patients from the TS who were assessed after administration of Spiriva, i.e. who have evaluable SGRQ measurements at visit 2 or visit 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With Spiriva | Additional Bronchodilator or Inhaled Corticosteroids (ICS) | 1146 Number of participants |
Secondary
Compliance of Patients
Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10.
Time frame: 6 months
Population: Patients from FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With Spiriva | Compliance of Patients | 3636 Number of participants |
Secondary
Patients With Any Adverse Events
Time frame: 6 months
Population: TS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With Spiriva | Patients With Any Adverse Events | 182 Number of participants |