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TerminatedNCT01907763Updated Jan 28, 2016

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

A Phase 3 interventional study of SOTB07 200mg and SOTB07 400mg in Asthma, sponsored by SK Chemicals Co., Ltd.. Terminated at 1 site in Korea, Republic of. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by SK Chemicals Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • SOTB07
03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's enrollment of 194 is above the median of 83 across 2,751 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

SK Chemicals Co., Ltd. is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
194 participants (actual)

Study arms

  • Experimental
    SOTB07 200mg

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

    Drug: SOTB07 200mg · Drug: SOTB 400mg placebo

  • Experimental
    SOTB07 400mg

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

    Drug: SOTB07 400mg · Drug: SOTB 200mg placebo

  • Placebo comparator
    Placebo

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

    Drug: SOTB 200mg placebo · Drug: SOTB 400mg placebo

Interventions

  • DrugSOTB07 200mg
  • DrugSOTB07 400mg
  • DrugSOTB 200mg placebo

    Placebo of SOTB07 200mg

  • DrugSOTB 400mg placebo

    Placebo of SOTB07 400mg

06

What researchers measure

Primary outcomes

  1. FEV1 change from the baseline

    Time frame: 12 weeks

Secondary outcomes

  1. Change in spirometer parameters

    Time frame: 12 weeks

  2. Change in FeNO

    Time frame: 12 weeks

  3. Change in AM/PM PEFR

    Time frame: 12 weeks

  4. Change in diurnal asthma symptom score

    Time frame: 12 weeks

  5. Change in the number of days with experience of nocturnal asthma symptoms

    Time frame: 12 weeks

  6. Change in amount of beta-2 agonist used (puff/day)

    Time frame: 12 weeks

  7. Proportion of rescue free day

    Time frame: 12 weeks

  8. Proportion of asthma control day

    Time frame: 12 weeks

  9. Proportion of asthma exacerbation

    Time frame: 12 weeks

  10. Proportion of treatment failure (severe asthma exacerbation)

    Time frame: 12 weeks

  11. Changes in asthma control questionaire score

    Time frame: 12 weeks

  12. Changes in quality of life questionaire for adult korea asthmatics scores

    Time frame: 12 weeks

  13. Changes in patient's global self assessment score

    Time frame: 12 weeks

  14. Change in visual analogue scale for cough score

    Time frame: 12 weeks

  15. Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample

    Time frame: 12 weeks

  16. Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample

    Time frame: 12 weeks

  17. Assessment of Safety

    Adverse Event/ Vital Sign/ Laboratory Test

    Time frame: 12 weeks

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01907763
Lead sponsor
SK Chemicals Co., Ltd.
Responsible party
Sponsor
First posted
Jul 25, 2013
Start date
Jan 2013
Primary completion
Oct 2015
Last update
Jan 28, 2016

Study contacts

Sangheon Cho, professor
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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