MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,328
- Locations
- 247
- Primary Endpoint
- Number of Patients Maintaining or Improving Their Health Status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
Eligibility Criteria
- Sex
- All
- Accepts 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.-
- •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.
Outcomes
Primary Outcomes
Number of Patients Maintaining or Improving Their Health Status
Time Frame: 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 Outcomes
- Change in the Total CAT Score (Value Baseline Minus 3 Months)(Baseline, 3 months)