Trial Outcomes & Findings for Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example (NCT NCT01036763)

Results Overview

Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful

Recruitment status

COMPLETED

Primary outcome timeframe

6 - 12 weeks

Results posted on

2014-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® 1 capsule/2 puffs once daily at the same time
Overall Study STARTED	1264
Overall Study COMPLETED	1171
Overall Study NOT COMPLETED	93

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® 1 capsule/2 puffs once daily at the same time
Overall Study Adverse Event	25
Overall Study Lost to Follow-up	28
Overall Study Other reason (not specified)	40

Baseline Characteristics

Assessment of Chronic Obstructive Pulmonary Disease (COPD) Therapy From the Physicians Perspective Using Tiotropium as an Example

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Age, Continuous	65.3 Years STANDARD_DEVIATION 10.5 • n=99 Participants
Age, Customized < 65 years	569 Years n=99 Participants
Age, Customized >= 65 years	695 Years n=99 Participants
Sex: Female, Male Female	466 Participants n=99 Participants
Sex: Female, Male Male	798 Participants n=99 Participants

PRIMARY outcome

Timeframe: 6 - 12 weeks

Population: All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics

Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Success of Treatment With Tiotropium According to Physician's Assessment Pulmonary function	620 Participants
Success of Treatment With Tiotropium According to Physician's Assessment Exercise capacity	618 Participants
Success of Treatment With Tiotropium According to Physician's Assessment Dyspnoea	452 Participants
Success of Treatment With Tiotropium According to Physician's Assessment Quality of life	412 Participants
Success of Treatment With Tiotropium According to Physician's Assessment Patient's opinion	235 Participants
Success of Treatment With Tiotropium According to Physician's Assessment Prevention of exacerbations	106 Participants

PRIMARY outcome

Timeframe: 6 - 12 weeks

Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Assessment of Efficacy According to Physician Very good	342 Participants
Assessment of Efficacy According to Physician Good	645 Participants
Assessment of Efficacy According to Physician Satisfactory	172 Participants
Assessment of Efficacy According to Physician Less satisfactory	44 Participants
Assessment of Efficacy According to Physician Unsatisfactory	27 Participants
Assessment of Efficacy According to Physician Missing	34 Participants

PRIMARY outcome

Timeframe: 6 - 12 weeks

Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Assessment of Tolerability According to Physician Very good	601 Participants
Assessment of Tolerability According to Physician Good	572 Participants
Assessment of Tolerability According to Physician Satisfactory	35 Participants
Assessment of Tolerability According to Physician Less satisfactory	9 Participants
Assessment of Tolerability According to Physician Unsatisfactory	13 Participants
Assessment of Tolerability According to Physician Missing	34 Participants

PRIMARY outcome

Timeframe: 6 - 12 weeks

patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Assessment of Efficacy According to Patient Very good	339 Participants
Assessment of Efficacy According to Patient Good	620 Participants
Assessment of Efficacy According to Patient Satisfactory	169 Participants
Assessment of Efficacy According to Patient Less satisfactory	55 Participants
Assessment of Efficacy According to Patient Unsatisfactory	35 Participants
Assessment of Efficacy According to Patient Missing	46 Participants

PRIMARY outcome

Timeframe: 6 - 12 weeks

Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Assessment of Tolerability According to Patient Satisfactory	54 Participants
Assessment of Tolerability According to Patient Very good	564 Participants
Assessment of Tolerability According to Patient Good	567 Participants
Assessment of Tolerability According to Patient Less satisfactory	14 Participants
Assessment of Tolerability According to Patient Unsatisfactory	17 Participants
Assessment of Tolerability According to Patient Missing	48 Participants

SECONDARY outcome

Timeframe: 0 weeks

Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores "Poor (1, 2)", "Satisfactory (3, 4)", "Good (5, 6)" and "Excellent (7, 8)" prior to treatment with Spiriva.

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Physician's Global Evaluation at Visit 1 Excellent	8 Participants
Physician's Global Evaluation at Visit 1 Good	294 Participants
Physician's Global Evaluation at Visit 1 Satisfactory	755 Participants
Physician's Global Evaluation at Visit 1 Poor	206 Participants
Physician's Global Evaluation at Visit 1 Missing	1 Participants

SECONDARY outcome

Timeframe: after 6 - 12 weeks

Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.

Outcome measures

Outcome measures
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 Participants 1 capsule/2 puffs once daily at the same time
Physician's Global Evaluation at Visit 2 Excellent	61 Participants
Physician's Global Evaluation at Visit 2 Good	737 Participants
Physician's Global Evaluation at Visit 2 Satisfactory	407 Participants
Physician's Global Evaluation at Visit 2 Poor	31 Participants
Physician's Global Evaluation at Visit 2 Missing	28 Participants

Adverse Events

Spiriva® 18 Microgram/Spiriva® Respimat®

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spiriva® 18 Microgram/Spiriva® Respimat® n=1264 participants at risk 1 capsule/2 puffs once daily at the same time
Cardiac disorders Coronary artery disease	0.08% 1/1264 • 6 - 12 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.08% 1/1264 • 6 - 12 weeks
General disorders Condition aggravated	0.08% 1/1264 • 6 - 12 weeks
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.08% 1/1264 • 6 - 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.08% 1/1264 • 6 - 12 weeks

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