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Completed

NCT Number: NCT01693471

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Senzoku Respiratory Disease and Allergy Clinic

Ōta-ku, Tokyo, 145-0063, Japan

About this study

Period: 2012-2013 Observation Time: 0 week, 4 week

Matters investigated:

  • QOL determination using SF-36 v2
  • Medication compliance (VAS scale)
  • Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Score of SF-36

    Time frame: 4 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyorin Pharmaceutical Co.,Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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