Survey on the Effect of Health Related Quality of Life (Q... | NCT01693471

Studies
Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients

NCT01693471

Sponsor

Kyorin Pharmaceutical Co.,Ltd

Status

Completed

Last Update Posted

Mar 1, 2013Estimated

Enrollment

179Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Japan

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

Feb 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

Sep 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Sep 21, 2012

First Submission Date that Met QC Criteria

Sep 24, 2012

First Posted Date

Sep 26, 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

Feb 27, 2013

Last Update Posted Date

Mar 1, 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

The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

Detailed Description

Period: 2012-2013 Observation Time: 0 week, 4 week

Matters investigated:

QOL determination using SF-36 v2
Medication compliance (VAS scale)
Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

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

179Actual

Label	Type	Description	Intervention Names
SEARCH Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Score of SF-36		4 week

Secondary Outcomes

Measure	Description	Time Frame
HR-QOL condition of asthma patients with phlegm		0 week
Medication compliance: measured by patient response to visual analog scale		4 week
Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female patients ≥ 20 years of age
Outpatients
Patients with mild or moderate persistent asthma
Patients with phlegm
Patients whose levels of asthma control are partly controlled or uncontrolled
Patients who are planned to treat MUCODYNE
Patients who voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria:

Patients with a history of adverse reactions to carbocisteine
Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
Patients with the possibility of pregnancy or suspected pregnancy
Patients with complication of malignancy
Current smoker
Patients with definitive diagnosis for COPD
Other patients whom investigators or subinvestigators considered inappropriate to participate in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

General Practitioner

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akito Saegusa, Mr.	Kyorin Pharmaceutical Co.,Ltd	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Senzoku Respiratory Disease and Allergy Clinic		Ōta-ku	Tokyo	145-0063	Japan

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided