N/A
N=2,031
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00624377 ↗Enrolled (actual)
2,031
Serious AEs
0.8%
Results posted
May 2012
Primary outcome: Primary: Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment — 1.16 Units on a Scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tiotropium (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment |
1.16 | — |
| PRIMARY Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment |
6.27 | — |
| PRIMARY Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment |
4.36 | — |
| SECONDARY Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment |
1.72 | — |
| SECONDARY Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment |
1.19 | — |
| SECONDARY Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment |
1.54 | — |
| SECONDARY Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs |
2.84 | — |
| SECONDARY Percentage of Participants Which Had a Reduction of Concomitant Drug Use |
76 | — |
Summary
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.
Eligibility Criteria
Inclusion criteria
- Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
- Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
- Tiotropium bromide naïve patients.
- Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.
Exclusion criteria
- Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
- Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
Data sourced from ClinicalTrials.gov (NCT00624377). 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.