Study Phase III Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

Asthma Clinical Trial

Official title:

A 12-week, Multi-center, Randomized, Double Blinded, Parallel Group, Placebo-controlled Study to Assess the Efficacy and Safety of SOTB07 in Asthma Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01907763
• Other study ID #: SOTB07_AST_III_2012
• Status: Terminated
• Phase: Phase 3
• First received: July 17, 2013
• Last updated: January 26, 2016
• Start date: January 2013

Study information

• Verified date: January 2016
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

A 12-week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled study to Assess the Efficacy and Safety of SOTB07 in asthma patients

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 = 80% 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 ß2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma

6. Clinically significant and uncontrolled psychiatric disease

7. history of drug or alcohol abuse

8. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1

9. Change of Immunotherapy within 6 months before visit 1

10. Administration of the antiasthma agent within 1 week of visit 1

11. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines

12. Participation in study using an experimental medication within 1 month before visit 1

13. Other ineligible subject in the opinion of the investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SOTB07 200mg

• SOTB07 400mg

• SOTB 200mg placebo
Placebo of SOTB07 200mg
• SOTB 400mg placebo
Placebo of SOTB07 400mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 change from the baseline		12 weeks	No
Secondary	Change in spirometer parameters		12 weeks	No
Secondary	Change in FeNO		12 weeks	No
Secondary	Change in AM/PM PEFR		12 weeks	No
Secondary	Change in diurnal asthma symptom score		12 weeks	Yes
Secondary	Change in the number of days with experience of nocturnal asthma symptoms		12 weeks	Yes
Secondary	Change in amount of beta-2 agonist used (puff/day)		12 weeks	Yes
Secondary	Proportion of rescue free day		12 weeks	Yes
Secondary	Proportion of asthma control day		12 weeks	Yes
Secondary	Proportion of asthma exacerbation		12 weeks	Yes
Secondary	Proportion of treatment failure (severe asthma exacerbation)		12 weeks	Yes
Secondary	Changes in asthma control questionaire score		12 weeks	No
Secondary	Changes in quality of life questionaire for adult korea asthmatics scores		12 weeks	No
Secondary	Changes in patient's global self assessment score		12 weeks	No
Secondary	Change in visual analogue scale for cough score		12 weeks	No
Secondary	Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in blood sample		12 weeks	No
Secondary	Change in biomarkers (eosinophil, neutrophil, ECP, eotaxin) in sputum sample		12 weeks	No
Secondary	Assessment of Safety	Adverse Event/ Vital Sign/ Laboratory Test	12 weeks	Yes