NCT01693471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

3 months

First QC Date

September 21, 2012

Last Update Submit

February 27, 2013

Conditions

Asthma

Keywords

asthmaSF-36HRQOL

Outcome Measures

Primary Outcomes (1)

  • Score of SF-36

    4 week

Secondary Outcomes (3)

  • HR-QOL condition of asthma patients with phlegm

    0 week

  • Medication compliance: measured by patient response to visual analog scale

    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

    0 week, 4 week

Study Arms (1)

SEARCH Study Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General Practitioner

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Senzoku Respiratory Disease and Allergy Clinic

Ōta-ku, Tokyo, 145-0063, Japan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Akito Saegusa, Mr.

    Kyorin Pharmaceutical Co.,Ltd

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2012

First Posted

September 26, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

JP(1)