Trial Outcomes & Findings for 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 (NCT NCT01644734)

Results Overview

The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1328 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2014-05-26

Participant Flow

46 patients were not documented to be treated with the study drug.

Participant milestones

Participant milestones
Measure	Patients Treated With Spiriva HandiHaler Inhalator is administered once daily in the dosage of 18µg.
Overall Study STARTED	1282
Overall Study COMPLETED	1016
Overall Study NOT COMPLETED	266

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Treated With Spiriva HandiHaler Inhalator is administered once daily in the dosage of 18µg.
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	17
Overall Study Reasons other than stated above	7
Overall Study Missing documentation	238

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Treated With Spiriva HandiHaler n=1282 Participants Inhalator is administered once daily in the dosage of 18µg.
Age, Continuous	64.2 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	494 Participants n=5 Participants
Sex: Female, Male Male	788 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.

The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.

Outcome measures

Outcome measures
Measure	Patients Treated With Spiriva HandiHaler n=1016 Participants Inhalator is administered once daily in the dosage of 18µg.
Number of Patients Maintaining or Improving Their Health Status	972 participants Interval 94.2 to 96.8

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Patients from FAS

The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.

Outcome measures

Outcome measures
Measure	Patients Treated With Spiriva HandiHaler n=1016 Participants Inhalator is administered once daily in the dosage of 18µg.
Change in the Total CAT Score (Value Baseline Minus 3 Months)	7.0 units on a scale Standard Deviation 5.9

Adverse Events

Patients Treated With Spiriva HandiHaler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

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