Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00936624
First received: July 8, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.


Condition Intervention Phase
Asthma
Drug: SOTB07
Drug: placebo
Drug: montelukast
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12 Week, Multi-center,Randomized, Double Blinded, Parallel Group, Placebo-controlled, 4-arm, Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Resource links provided by NLM:


Further study details as provided by SK Chemicals Co.,Ltd.:

Primary Outcome Measures:
  • % change from baseline for FEV1 at each visit [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 245
Study Start Date: July 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOTB07 100mg Drug: SOTB07
SOTB07 100mg
Experimental: SOTB07 200mg Drug: SOTB07
SOTB07 200mg
Placebo Comparator: Placebo Drug: placebo
placebo
Active Comparator: Montelukast 10mg Drug: montelukast
montelukast 10mg po, bid, 12week

Detailed Description:

A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ≤ 85% 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 or history of drug or alcohol abuse
  7. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
  8. Change of Immunotherapy within 6 months before visit 1
  9. Administration of the antiasthma agent within 1 week of visit 1
  10. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
  11. Participation in study using an experimental medication within 1 month before visit 1
  12. Other ineligible subject in the opinion of the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936624

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
SK Chemicals Co.,Ltd.
Investigators
Principal Investigator: Sangheon Cho, professor Seoul National University Hospital
  More Information

No publications provided

Responsible Party: SK Chemicals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00936624     History of Changes
Other Study ID Numbers: SOTB07_AST_II_2008
Study First Received: July 8, 2009
Last Updated: December 17, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by SK Chemicals Co.,Ltd.:
Persistent asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014