Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.
Interventions
Sponsors
Pfizer
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male and female ambulatory outpatients being seen in a participating physicians office for routine care, * Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1), * Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment, * Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.
Exclusion criteria
* Uncooperative patients as judged by the physician, * Patients with any conditions excluded as per Country specific package insert, * Patients currently enrolled in any clinical trial, * Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Maintaining or Improving Their Health Status | Baseline, 3 months | The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Total CAT Score (Value Baseline Minus 3 Months) | Baseline, 3 months | The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement. |
Countries
Poland
Participant flow
Pre-assignment details
46 patients were not documented to be treated with the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With Spiriva HandiHaler Inhalator is administered once daily in the dosage of 18µg. | 1,282 |
| Total | 1,282 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 17 |
| Overall Study | Missing documentation | 238 |
| Overall Study | Reasons other than stated above | 7 |
Baseline characteristics
| Characteristic | Patients Treated With Spiriva HandiHaler |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 494 Participants |
| Sex: Female, Male Male | 788 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,282 |
| serious Total, serious adverse events | 0 / 1,282 |
Outcome results
Primary
Number of Patients Maintaining or Improving Their Health Status
The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.
Time frame: Baseline, 3 months
Population: Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With Spiriva HandiHaler | Number of Patients Maintaining or Improving Their Health Status | 972 participants |
Secondary
Change in the Total CAT Score (Value Baseline Minus 3 Months)
The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.
Time frame: Baseline, 3 months
Population: Patients from FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Treated With Spiriva HandiHaler | Change in the Total CAT Score (Value Baseline Minus 3 Months) | 7.0 units on a scale | Standard Deviation 5.9 |
Comparison: Null hypothesis: no change in the total CAT score between baseline and after 3 months.p-value: <0.001t-test, 2 sided