Observational Non-Interventional Study With Spiriva Respi... | NCT00699699

Status Module

Sponsor/Collaborators Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Therapeutic Success as Change From Baseline in Physical Functioning 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)	Baseline and after 6 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the PF-10 Score 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)	Baseline and after 6 weeks of treatment
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Aachen			Germany
Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00065.5± 10.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000500
Male	BG000780

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Therapeutic Success as Change From Baseline in Physical Functioning 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)

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

Posted

Number

Percentage of participants

Baseline and after 6 weeks of treatment

ID	Title	Description
OG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Units	Counts
Participants	OG0001230

Title

Denominators

Categories

Title	Measurements
	OG00061.5

Secondary

Change From Baseline in the PF-10 Score 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)

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

Posted

Mean

Standard Deviation

PF-10 score points

Baseline and after 6 weeks of treatment

ID	Title	Description
OG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Units	Counts
Participants	OG0001230

Secondary

Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety

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))

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

Posted

Mean

Standard Deviation

PGE scale points

Baseline and after 6 weeks of treatment

ID	Title	Description
OG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Units	Counts
Participants	OG0001260

Secondary

Patients' Satisfaction After 6 Weeks of Treatment

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")

There were 1260 patients who had evaluable PGE after 6 weeks

Posted

Number

Participants

6 weeks

ID	Title	Description
OG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time

Units	Counts
Participants	OG0001260

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Spiriva® Respimat® 2 Puffs Once Daily at the Same Time				6	1,280	0	1,280

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tachycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk
Bronchitis, Infective exacerbation of chronic obstructive airways disease, Urinary tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected1,280 at risk
Bronchial carcinoma, Laryngeal cancer, Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0002 affected1,280 at risk
Convulsion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk
Azotaemia, Urinary retention	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk
BPH	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk
Dyspnoea, Pleural effusion, Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected1,280 at risk
Circulatory collapse	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected1,280 at risk

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Title

Denominators

Categories

Very satisfied

Title	Measurements
	OG000433

Satisfied

Title	Measurements
	OG000551

Rather satisfied

Title	Measurements
	OG000145

Neither / nor

Title	Measurements
	OG00077

Rather dissatisfied

Title	Measurements
	OG00024

Dissatisfied

Title	Measurements
	OG00021

Very dissatisfied

Title	Measurements
	OG0009