Study of the Impact of Indacaterol (Onbrez®) on the Indiv... | NCT02123199

Studies
Study of the Impact of Indacaterol (Onbrez®) on the Individual Lives and Health Status of Patients With COPD

NCT02123199

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 25, 2014Estimated

Enrollment

103Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol (Onbrez®) /QAB149

Countries

United Kingdom

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

Apr 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 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Not provided

First Submitted Date

Apr 22, 2014

First Submission Date that Met QC Criteria

Apr 24, 2014

First Posted Date

Apr 25, 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

Apr 24, 2014

Last Update Posted Date

Apr 25, 2014Estimated

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

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indacaterol/QAB149		Patients treated with Indacaterol for COPD prior to enrollment in study	Drug: Indacaterol (Onbrez®) /QAB149

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol (Onbrez®) /QAB149	Drug		Indacaterol/QAB149

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in COPD assessment Test (CAT Score) at 6-8 weeks after the initiation of indacaterol		6-8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in COPD Assessment test (CAT) score at 6 months after the initiation of indacaterol		6 months
Impact of indacaterol on patients' lies at 6 - 8 weeks after the initiation of indacaterol.		6-8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with active diagnosis of COPD, confirmed by spirometry documented in medical notes

Exclusion Criteria:

Patients who are currently receiving other maintenance therapy (except LAMA) for COPD.
Patients previously prescribed Indacaterol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients will be recruited only after indacaterol has been prescribed and is being used for the patients first maintenance therapy for COPD symptoms.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		London	London		United Kingdom

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
C510790	indacaterol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided