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

NCT ID: NCT00936624

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Keywords

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Persistent asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SOTB07 100mg

Group Type EXPERIMENTAL

SOTB07

Intervention Type DRUG

SOTB07 100mg

SOTB07 200mg

Group Type EXPERIMENTAL

SOTB07

Intervention Type DRUG

SOTB07 200mg

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Montelukast 10mg

Group Type ACTIVE_COMPARATOR

montelukast

Intervention Type DRUG

montelukast 10mg po, bid, 12week

Interventions

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SOTB07

SOTB07 100mg

Intervention Type DRUG

SOTB07

SOTB07 200mg

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

montelukast

montelukast 10mg po, bid, 12week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangheon Cho, professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SOTB07_AST_II_2008

Identifier Type: -

Identifier Source: org_study_id