NCT01907763

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.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
194

participants targeted

Target at P25-P50 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

July 17, 2013

Last Update Submit

January 26, 2016

Conditions

Asthma

Keywords

asthmaSOTB07

Outcome Measures

Primary Outcomes (1)

  • FEV1 change from the baseline

    12 weeks

Secondary Outcomes (17)

  • Change in spirometer parameters

    12 weeks

  • Change in FeNO

    12 weeks

  • Change in AM/PM PEFR

    12 weeks

  • Change in diurnal asthma symptom score

    12 weeks

  • Change in the number of days with experience of nocturnal asthma symptoms

    12 weeks

  • +12 more secondary outcomes

Study Arms (3)

SOTB07 200mg

EXPERIMENTAL

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

Drug: SOTB07 200mgDrug: SOTB 400mg placebo

SOTB07 400mg

EXPERIMENTAL

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

Drug: SOTB07 400mgDrug: SOTB 200mg placebo

Placebo

PLACEBO COMPARATOR

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

Drug: SOTB 200mg placeboDrug: SOTB 400mg placebo

Interventions

SOTB07 200mgDRUG
SOTB07 200mg
SOTB07 400mgDRUG
SOTB07 400mg
SOTB 200mg placeboDRUG

Placebo of SOTB07 200mg

PlaceboSOTB07 400mg
SOTB 400mg placeboDRUG

Placebo of SOTB07 400mg

PlaceboSOTB07 200mg

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sangheon Cho, professor

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 25, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2015

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

KR(1)