Phase 4
Completed N=1,282
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
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01644734 ↗
Enrolled (actual)
1,282
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Number of Patients Maintaining or Improving Their Health Status — 972 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Maintaining or Improving Their Health Status |
972 | — |
| SECONDARY Change in the Total CAT Score (Value Baseline Minus 3 Months) |
7.0 | <0.001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01644734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.