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

February 27, 2013 updated by: Kyorin Pharmaceutical Co.,Ltd

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Ota-ku, Tokyo, Japan, 145-0063
        • Senzoku Respiratory Disease and Allergy Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

General Practitioner

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
SEARCH Study Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score of SF-36
Time Frame: 4 week
4 week

Secondary Outcome Measures

Outcome Measure
Time Frame
HR-QOL condition of asthma patients with phlegm
Time Frame: 0 week
0 week
Medication compliance: measured by patient response to visual analog scale
Time Frame: 4 week
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
Time Frame: 0 week, 4 week
0 week, 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin Pharmaceutical Co.,Ltd

Investigators

  • Study Chair: Akito Saegusa, Mr., Kyorin Pharmaceutical Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 27, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEARCH-2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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