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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936624
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: SOTB07 Drug: placebo Drug: montelukast Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arm Intervention/treatment
Experimental: SOTB07 100mg Drug: SOTB07
SOTB07 100mg

Experimental: SOTB07 200mg Drug: SOTB07
SOTB07 200mg

Placebo Comparator: Placebo Drug: placebo

Active Comparator: Montelukast 10mg Drug: montelukast
montelukast 10mg po, bid, 12week

Primary Outcome Measures :
  1. % change from baseline for FEV1 at each visit [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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 ≤ 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00936624

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

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT00936624     History of Changes
Other Study ID Numbers: SOTB07_AST_II_2008
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action