Trial Outcomes & Findings for Observational Non-Interventional Study With Spiriva Respimat in COPD Patients (NCT NCT00699699)

Results Overview

Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

Recruitment status

COMPLETED

Target enrollment

1280 participants

Primary outcome timeframe

Baseline and after 6 weeks of treatment

Results posted on

2014-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time
Overall Study STARTED	1280
Overall Study COMPLETED	1223
Overall Study NOT COMPLETED	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time
Overall Study Adverse Event	36
Overall Study Individual different reasons	21

Baseline Characteristics

Observational Non-Interventional Study With Spiriva Respimat in COPD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1280 Participants
Age, Continuous	65.5 Years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	500 Participants n=5 Participants
Sex: Female, Male Male	780 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after 6 weeks of treatment

Population: There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks

Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

Outcome measures

Outcome measures
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1230 Participants
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks	61.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and after 6 weeks of treatment

Population: There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks

Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)

Outcome measures

Outcome measures
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1230 Participants
Change From Baseline in the PF-10 Score After 6 Weeks	13.4 PF-10 score points Standard Deviation 15.9

SECONDARY outcome

Timeframe: Baseline and after 6 weeks of treatment

Population: There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks

Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))

Outcome measures

Outcome measures
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1260 Participants
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety	1.1 PGE scale points Standard Deviation 1.2

SECONDARY outcome

Timeframe: 6 weeks

Population: There were 1260 patients who had evaluable PGE after 6 weeks

Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")

Outcome measures

Outcome measures
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1260 Participants
Patients' Satisfaction After 6 Weeks of Treatment Satisfied	551 Participants
Patients' Satisfaction After 6 Weeks of Treatment Rather satisfied	145 Participants
Patients' Satisfaction After 6 Weeks of Treatment Very satisfied	433 Participants
Patients' Satisfaction After 6 Weeks of Treatment Neither / nor	77 Participants
Patients' Satisfaction After 6 Weeks of Treatment Rather dissatisfied	24 Participants
Patients' Satisfaction After 6 Weeks of Treatment Dissatisfied	21 Participants
Patients' Satisfaction After 6 Weeks of Treatment Very dissatisfied	9 Participants

Adverse Events

Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time n=1280 participants at risk
Cardiac disorders Tachycardia	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population
Gastrointestinal disorders Constipation	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population
Infections and infestations Bronchitis, Infective exacerbation of chronic obstructive airways disease, Urinary tract infection	0.23% 3/1280 • 6 weeks There were 1280 patients in the safety population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma, Laryngeal cancer, Metastatic renal cell carcinoma	0.16% 2/1280 • 6 weeks There were 1280 patients in the safety population
Nervous system disorders Convulsion	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population
Renal and urinary disorders Azotaemia, Urinary retention	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population
Reproductive system and breast disorders BPH	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population
Respiratory, thoracic and mediastinal disorders Dyspnoea, Pleural effusion, Sputum discoloured	0.16% 2/1280 • 6 weeks There were 1280 patients in the safety population
Vascular disorders Circulatory collapse	0.08% 1/1280 • 6 weeks There were 1280 patients in the safety population

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