Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

Conditions

Pulmonary Disease, Chronic Obstructive

Brief 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.

Related papers

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Interventions

DRUGTiotropium

Tiotropium 18 mcg HandiHaler once daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

1. Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005). 2. Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication. 3. Tiotropium bromide naïve patients. 4. Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.

Exclusion criteria

1. Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert). 2. Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.

Design outcomes

Primary

Measure	Time frame	Description
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	Baseline and 8 weeks	The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?
Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment	Baseline and 8 weeks	FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 \< 80% of the predicted value in combination with an FEV1/FVC \< 70% confirms the presence of airflow limitation that is not fully reversible
Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment	Baseline and 8 weeks	FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (\<80%, often \ 45%).

Secondary

Measure	Time frame	Description
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	Baseline and 8 weeks	The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment	Baseline and 8 weeks	The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?
Percentage of Participants Which Had a Reduction of Concomitant Drug Use	8 weeks	The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment	Baseline and 8 weeks	The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment	Baseline and 8 weeks	The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?

Countries

Taiwan

Participant flow

Recruitment details

A total of 2,031 patients were enrolled between Jan-11-2008 to Mar-24-2010

Participants by arm

Arm	Count
Spiriva 18µg With HandiHaler Device on COPD Patients	2,031
Total	2,031

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	14
Overall Study	Lost to Follow-up	355
Overall Study	Non-evaluable population	84
Overall Study	Other	91
Overall Study	Withdrawal by Subject	100

Baseline characteristics

Characteristic	Spiriva 18µg With HandiHaler Device on COPD Patients
Age, Customized	72.87 Year STANDARD_DEVIATION 10.32
Gender Female	245 Participants
Gender Male	1781 Participants
Height	162.57 cm STANDARD_DEVIATION 7.38
Weight	61.94 kg STANDARD_DEVIATION 11.6

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 2,031
serious Total, serious adverse events	16 / 2,031

Outcome results

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

The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question Overall, how is the COPD of your patient?