Trial Outcomes & Findings for Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice (NCT NCT00624377)

NCT ID: NCT00624377

Last Updated: 2014-03-28

Results Overview

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?"

• Recruitment status: COMPLETED
• Target enrollment: 2031 participants
• Primary outcome timeframe: Baseline and 8 weeks
• Results posted on: 2014-03-28

Participant Flow

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

Participant milestones

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients
Overall Study STARTED	2031
Overall Study COMPLETED	1387
Overall Study NOT COMPLETED	644

Reasons for withdrawal

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients
Overall Study Lost to Follow-up	355
Overall Study Withdrawal by Subject	100
Overall Study Adverse Event	14
Overall Study Other	91
Overall Study Non-evaluable population	84

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=2031 Participants
Age, Customized	72.87 Year STANDARD_DEVIATION 10.32 • n=5 Participants
Gender Female	245 Participants n=5 Participants
Gender Male	1781 Participants n=5 Participants
Weight	61.94 kg STANDARD_DEVIATION 11.60 • n=5 Participants
Height	162.57 cm STANDARD_DEVIATION 7.38 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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?"

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=232 Participants
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 Standard Deviation 1.34

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=1386 Participants
Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment	6.27 liter per second Standard Deviation 12.99

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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%).

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=1383 Participants
Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment	4.36 Ratio Standard Deviation 10.72

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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?"

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=408 Participants
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 Units on a Scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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?"

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=913 Participants
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 Units on a Scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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?"

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=1387 Participants
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 Units on a Scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

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?"

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=247 Participants
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 Units on a Scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: 8 weeks

Population: Safety population: Safety population will be defined as all patients enrolled in the study. Safety endpoints will be analyzed based on the safety population. Complete population: Complete population was defined as the subjects who completed 3 visit measurements. Efficacy endpoints will be analyzed based on the completed population.

The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.

Outcome measures

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=1387 Participants
Percentage of Participants Which Had a Reduction of Concomitant Drug Use	76 Percentage of Participants

Adverse Events

Spiriva 18µg With HandiHaler Device on COPD Patients

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Spiriva 18µg With HandiHaler Device on COPD Patients n=2031 participants at risk
Cardiac disorders Cardiac disorder	0.05% 1/2031 • 8 weeks
General disorders Death	0.10% 2/2031 • 8 weeks
Hepatobiliary disorders Hepatic cirrhosis	0.05% 1/2031 • 8 weeks
Infections and infestations Pneumonia	0.05% 1/2031 • 8 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.05% 1/2031 • 8 weeks
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.05% 1/2031 • 8 weeks
Respiratory, thoracic and mediastinal disorders Chronic Obstructive pulmonary disease	0.20% 4/2031 • 8 weeks
Surgical and medical procedures Respiratory therapy	0.05% 1/2031 • 8 weeks
Vascular disorders Infarction	0.05% 1/2031 • 8 weeks
Cardiac disorders Acute Myocardial Infarction	0.10% 2/2031 • 8 weeks
Cardiac disorders Cynosis	0.05% 1/2031 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER