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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
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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
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 June 18, 2013