Effect of Spiriva® on Health-related Quality of Life in C... | NCT02172547

Studies
Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.

NCT02172547

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jun 24, 2014Estimated

Enrollment

10,821Actual

Phase

Not provided

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spiriva

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Jan 2007Actual

Completion Date

Not provided

First Submitted Date

Jun 20, 2014

First Submission Date that Met QC Criteria

Jun 20, 2014

First Posted Date

Jun 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2014

Last Update Posted Date

Jun 24, 2014Estimated

Description Module

Brief Summary

Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,821Actual

Label	Type	Description	Intervention Names
COPD patients who stopped smoking during treatment			Drug: Spiriva

Name	Type	Description	Arm Group Labels	Other Names
Spiriva	Drug		COPD patients who stopped smoking during treatment

Measure	Description	Time Frame
Changes in health related quality of life		6 weeks

Measure	Description	Time Frame
Occurrence of Adverse events		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with COPD
Smoker at start

Exclusion Criteria:

Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General Practioner

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069447	Tiotropium Bromide

Ancestor Terms

ID	Term
D012602	Scopolamine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Browse Leaves

Not provided

Browse Branches

Not provided