Correlation Between Patient Perception and Findings on Cl... | NCT01703416

Studies
Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01703416

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Apr 25, 2013Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Not provided

Countries

Bulgaria

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 2013

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

Oct 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Apr 2013Actual

First Submitted Date

Oct 3, 2012

First Submission Date that Met QC Criteria

Oct 8, 2012

First Posted Date

Oct 10, 2012Estimated

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, 2013

Last Update Posted Date

Apr 25, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.

Detailed Description

CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

500Actual

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in CDLM (Capacity of Daily Living during the Morning) questionnaire.		Baseline and 3 months
Change from baseline of patient's general health status upon physical evaluation - visual scale		Baseline and 3 months

Secondary Outcomes

Measure	Description	Time Frame
Age (years), gender (male/female), weight (kg), height (cm), place of origin (urban/rural)	Descriptive statistics will be calculated for this outcome measure	Day 0 (visit 1)
Number of daily walking steps (by using pedometers)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
Current or past smokers, of at least 10 pack years

Exclusion Criteria:

History of exacerbation of COPD symptoms within the last month before visit 1, inclusive.
History of asthma or allergic rhinitis.
History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Chronic Obstructive Pulmonary Disease (COPD) patients group C and D

Sampling Method

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

Facility	Status	City	State	ZIP	Country	Contacts
		Sofia			Bulgaria