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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01693471
First received: September 21, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)

Resource links provided by NLM:


Further study details as provided by Kyorin Pharmaceutical Co.,Ltd:

Primary Outcome Measures:
  • Score of SF-36 [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HR-QOL condition of asthma patients with phlegm [ Time Frame: 0 week ] [ Designated as safety issue: No ]
  • Medication compliance: measured by patient response to visual analog scale [ Time Frame: 4 week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
SEARCH Study Group

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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General Practitioner

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693471

Locations
Japan
Senzoku Respiratory Disease and Allergy Clinic
Ota-ku, Tokyo, Japan, 145-0063
Sponsors and Collaborators
Kyorin Pharmaceutical Co.,Ltd
Investigators
Study Chair: Akito Saegusa, Mr. Kyorin Pharmaceutical Co.,Ltd
  More Information

No publications provided

Responsible Party: Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01693471     History of Changes
Other Study ID Numbers: SEARCH-2012
Study First Received: September 21, 2012
Last Updated: February 27, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
asthma
SF-36
HRQOL

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Carbocysteine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014