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

NCT ID: NCT01693471

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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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

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

Matters investigated:

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

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SEARCH Study Group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyorin Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akito Saegusa, Mr.

Role: STUDY_CHAIR

Kyorin Pharmaceutical Co.,Ltd

Locations

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Senzoku Respiratory Disease and Allergy Clinic

Ōta-ku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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SEARCH-2012

Identifier Type: -

Identifier Source: org_study_id

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