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Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SOTB07 200mg
SOTB07 400mg
SOTB 200mg placebo
SOTB 400mg placebo
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, SOTB07

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or eligible female subjects aged 15 years or more
  2. A female is eligible if she is of:

    • Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
    • Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
    • Negative pregnancy test at screening
  3. Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
  4. Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)

6.FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained

Exclusion Criteria:

  1. Active upper or lower respiratory tract infection within 3 weeks before visit 1
  2. Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
  3. Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
  4. Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
  5. Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
  6. Clinically significant and uncontrolled psychiatric disease
  7. history of drug or alcohol abuse
  8. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
  9. Change of Immunotherapy within 6 months before visit 1
  10. Administration of the antiasthma agent within 1 week of visit 1
  11. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
  12. Participation in study using an experimental medication within 1 month before visit 1
  13. Other ineligible subject in the opinion of the investigator

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SOTB07 200mg

SOTB07 400mg

Placebo

Arm Description

One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day.

One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day.

One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day.

Outcomes

Primary Outcome Measures

FEV1 change from the baseline

Secondary Outcome Measures

Change in spirometer parameters
Change in FeNO
Change in AM/PM PEFR
Change in diurnal asthma symptom score
Change in the number of days with experience of nocturnal asthma symptoms
Change in amount of beta-2 agonist used (puff/day)
Proportion of rescue free day
Proportion of asthma control day
Proportion of asthma exacerbation
Proportion of treatment failure (severe asthma exacerbation)
Changes in asthma control questionaire score
Changes in quality of life questionaire for adult korea asthmatics scores
Changes in patient's global self assessment score
Change in visual analogue scale for cough score
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
Assessment of Safety
Adverse Event/ Vital Sign/ Laboratory Test

Full Information

First Posted
July 17, 2013
Last Updated
January 26, 2016
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01907763
Brief Title
Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
Official Title
A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the efficacy and safety of SOTB07 in asthma patients by observing changes FEV1 (% predicted) as the primary efficacy endpoint after oral administration of SOTB07 200mg, 400mg, placebo for 12 weeks.
Detailed Description
A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, SOTB07

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOTB07 200mg
Arm Type
Experimental
Arm Description
One tablet of SOTB07 200mg and One tablet of SOTB 400mg Placebo are administered twice a day.
Arm Title
SOTB07 400mg
Arm Type
Experimental
Arm Description
One tablet of SOTB07 400mg and One tablet of SOTB 200mg Placebo are administered twice a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet of SOTB 200mg Placebo and One tablet of SOTB 400mg Placebo are administered twice a day.
Intervention Type
Drug
Intervention Name(s)
SOTB07 200mg
Intervention Type
Drug
Intervention Name(s)
SOTB07 400mg
Intervention Type
Drug
Intervention Name(s)
SOTB 200mg placebo
Intervention Description
Placebo of SOTB07 200mg
Intervention Type
Drug
Intervention Name(s)
SOTB 400mg placebo
Intervention Description
Placebo of SOTB07 400mg
Primary Outcome Measure Information:
Title
FEV1 change from the baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in spirometer parameters
Time Frame
12 weeks
Title
Change in FeNO
Time Frame
12 weeks
Title
Change in AM/PM PEFR
Time Frame
12 weeks
Title
Change in diurnal asthma symptom score
Time Frame
12 weeks
Title
Change in the number of days with experience of nocturnal asthma symptoms
Time Frame
12 weeks
Title
Change in amount of beta-2 agonist used (puff/day)
Time Frame
12 weeks
Title
Proportion of rescue free day
Time Frame
12 weeks
Title
Proportion of asthma control day
Time Frame
12 weeks
Title
Proportion of asthma exacerbation
Time Frame
12 weeks
Title
Proportion of treatment failure (severe asthma exacerbation)
Time Frame
12 weeks
Title
Changes in asthma control questionaire score
Time Frame
12 weeks
Title
Changes in quality of life questionaire for adult korea asthmatics scores
Time Frame
12 weeks
Title
Changes in patient's global self assessment score
Time Frame
12 weeks
Title
Change in visual analogue scale for cough score
Time Frame
12 weeks
Title
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample
Time Frame
12 weeks
Title
Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample
Time Frame
12 weeks
Title
Assessment of Safety
Description
Adverse Event/ Vital Sign/ Laboratory Test
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or eligible female subjects aged 15 years or more A female is eligible if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly Negative pregnancy test at screening Non-smoker for at least 1 year, a pack history of ≤ 10 pack years Symptom of persistent asthma, as defined by the National Institute of Health (NIH) 5.50% ≤ FEV1 ≤ 80% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours) 6.FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1 7.Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8.Appropriately signed and dated informed consent has been obtained Exclusion Criteria: Active upper or lower respiratory tract infection within 3 weeks before visit 1 Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1 Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1 Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma Clinically significant and uncontrolled psychiatric disease history of drug or alcohol abuse Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 Change of Immunotherapy within 6 months before visit 1 Administration of the antiasthma agent within 1 week of visit 1 Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines Participation in study using an experimental medication within 1 month before visit 1 Other ineligible subject in the opinion of the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangheon Cho, professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

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