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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01693471

Enrollment

179

Registered

2012-09-26

Start date

2012-09-30

Completion date

2013-01-31

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, SF-36, HRQOL

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Score of SF-36	4 week

Secondary

Measure	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	0 week, 4 week

Countries

Japan

Outcome results