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

Completed

• Conditions: Asthma

• Registration Number: NCT01693471
• Lead Sponsor: Kyorin Pharmaceutical Co.,Ltd

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:

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Score of SF-36	4 week

Secondary Outcome Measures

Name	Time	Method
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	0 week, 4 week

Trial Locations

Locations (1)

Senzoku Respiratory Disease and Allergy Clinic; 🇯🇵 Ota-ku, Tokyo, Japan