AsthmaNCT01693471
Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients
An observational study of Asthma, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Asthma
- How many people
- 179 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: General Practitioner
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Senzoku Respiratory Disease and Allergy Clinic
Ōta-ku, Tokyo, 145-0063
About this study
Official title: Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)
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.
Read the detailed description
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
- Conditions
- Asthma
- Keywords
- asthma, SF-36, HRQOL
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SEARCH Study Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of SF-36
Measured: 4 week
Secondary outcomes (3)
HR-QOL condition of asthma patients with phlegm
Measured: 0 week
Medication compliance: measured by patient response to visual analog scale
Measured: 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
Measured: 0 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akito Saegusa, Mr., Study chair, Kyorin Pharmaceutical Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693471
- Sponsor's protocol ID
- SEARCH-2012
- Status last verified
- Feb 2013
- First submitted
- 21 Sep 2012
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)
- ClinicalTrials.gov ID
- NCT01693471
- Acronym / sponsor ID
- SEARCH-2012
- Conditions
- Asthma
- Keywords
- asthma, SF-36, HRQOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Kyorin Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEARCH Study Group | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General Practitioner
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Score of SF-36
Time frame: 4 week
3 secondary outcomes
HR-QOL condition of asthma patients with phlegm
Time frame: 0 week
Medication compliance: measured by patient response to visual analog scale
Time frame: 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
Time frame: 0 week, 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akito Saegusa, Mr. study chair
Kyorin Pharmaceutical Co.,Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Kyorin Pharmaceutical Co.,Ltd at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of SF-36 (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2013.