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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693471
• Other study ID #: SEARCH-2012
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: February 27, 2013
• Start date: September 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Kyorin Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Japan	Senzoku Respiratory Disease and Allergy Clinic	Ota-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of SF-36		4 week	No
Secondary	HR-QOL condition of asthma patients with phlegm		0 week	No
Secondary	Medication compliance: measured by patient response to visual analog scale		4 week	No
Secondary	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	No