Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Spiriva HandiHaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644734

205.502

Details and patient eligibility

About

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.

Enrollment: 1,328 patients

Sex: All

Volunteers: No Healthy Volunteers

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.