Patient's Perception in Symptoms Related to Morning Activ... | NCT00894426

Studies
Patient's Perception in Symptoms Related to Morning Activity Based on Chronic Obstructive Lung Disease

NCT00894426

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

COPD

Interventions

Not provided

Countries

South Korea

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

Dec 2010

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

May 2009

Primary Completion Date

Not provided

Completion Date

Dec 2009Actual

First Submitted Date

Apr 28, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 2009Estimated

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

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

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

The aim of this study is to assess the perception of chronic obstructive pulmonary disease (COPD) patients in symptoms related to morning activities. Also the researchers investigated how to describe the impact of symptoms on sleep quality and how to use the medication in Korea COPD treatments.

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

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Morning Symptoms (+)
2		Morning Symptoms (-)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the perception of COPD Patients in symptoms related to morning activities		At baseline and last visit (after 2~3 months)

Secondary Outcomes

Measure	Description	Time Frame
To assess the patient's perception of the variability of symptoms		At baseline and last visit (after 2~3 months)
To describe how patients use their COPD treatments		At baseline and last visit (after 2~3 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD outpatients over 45 years old
Lung function: post-FEV1 < 50%
Current or ex-smoker > 10 packs per year
Patients who were not on medication of ISC/FC at least 2 weeks

Exclusion Criteria:

Ongoing exacerbation of COPD or within the previous 3 months
History of asthma or allergic rhinitis
Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
Current participation in an interventional clinical trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The inclusion/exclusion criteria are designed to select subjects suffering from severe COPD (according to spirometric classification, GOLD stage III and IV) and in a stable state

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joonwoo Bahn	Astrazenca Korea, Medical Department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Daegu			South Korea
Research Site

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