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

NCT00936624 | Completed Phase 2 DMC

• 1 other identifier: SOTB07_AST_II_2008
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Persistent asthma

Outcome Measures

Primary Outcomes (1)

• % change from baseline for FEV1 at each visit

  12 weeks

Study Arms (4)

SOTB07 100mg

EXPERIMENTAL

Drug: SOTB07

SOTB07 200mg

EXPERIMENTAL

Drug: SOTB07

Placebo

PLACEBO COMPARATOR

Drug: placebo

Montelukast 10mg

ACTIVE COMPARATOR

Drug: montelukast

Interventions

SOTB07 DRUG

SOTB07 100mg

SOTB07 100mg

placebo DRUG

placebo

Placebo

montelukast DRUG

montelukast 10mg po, bid, 12week

Montelukast 10mg

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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)
• % ≤ FEV1 ≤ 85% 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
• Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits
• 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 or 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

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sangheon Cho, professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 8, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

KR (1)