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

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ClinicalTrials.gov Identifier: NCT01693471
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : March 1, 2013
Sponsor:
Information provided by (Responsible Party):
Kyorin Pharmaceutical Co.,Ltd

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.

Condition or disease
Asthma

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

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Study Type : Observational
Actual Enrollment : 179 participants
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)
Study Start Date : September 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
SEARCH Study Group



Primary Outcome Measures :
  1. Score of SF-36 [ Time Frame: 4 week ]

Secondary Outcome Measures :
  1. HR-QOL condition of asthma patients with phlegm [ Time Frame: 0 week ]
  2. Medication compliance: measured by patient response to visual analog scale [ Time Frame: 4 week ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693471


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

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Responsible Party: Kyorin Pharmaceutical Co.,Ltd
ClinicalTrials.gov Identifier: NCT01693471    
Other Study ID Numbers: SEARCH-2012
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: March 1, 2013
Last Verified: February 2013
Keywords provided by Kyorin Pharmaceutical Co.,Ltd:
asthma
SF-36
HRQOL
Additional relevant MeSH terms:
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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
Expectorants
Respiratory System Agents