Asthma
Conditions
Brief summary
The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma. The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.
Detailed description
Singulair: Montelukast sodium (leukotriene modulator)
Interventions
Tablet, three times daily / 8 weeks
Tablet, three times daily / 8 weeks
DRUGSingulair
Tablet, one times daily / 8 weeks
DRUGPlacebo
Tablet, one times daily / 7 days
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed written informed consent * Acceptable medical history, physical exam,laboratory tests and EKG, during screening * Nonsmoking (for longer than 1 year) patients with asthma * Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist * FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)
Exclusion criteria
* History of any clinically significant disease * History of drug/chemical/alcohol abuse * Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of FEV1 at week 4 | Baseline, week 4 | FEV1: Forced Expiratory Volume In One Second |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of FEV1 at week 8 | Baseline, week 8 | — |
| Change from baseline of PEFR at week 8 | Baseline, week 8 | PEFR: Peak Expiratory Flow Rate |
| Change from baseline of ACT Score at week 8 | Baseline, week 8 | ACT: Asthma control test |
| Change from baseline of using rescue medication(b-Agonist) at week 8 | Baseline, week 8 | — |
| safety assessment | week 9 | Comparison of the adverse event profiles throughout the course of the study |
Countries
South Korea
Outcome results
None listed