Efficacy and Safety of HCP1102 Capsule

Hanmi Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Asthma With Allergic Rhinitis

Treatments

Drug: HCP1102+HGP0711Placebo

Drug: HCP1102Placebo+HGP0711

Study type

Interventional

Funder types

Industry

Identifiers

HM-MOLZ-302

Details and patient eligibility

About

Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Enrollment

228 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

Age≥15
Mild or moderate asthma patients with allergic rhinitis
Patient who meet all criteria of rhinitis
Patients understood the contents and purpose of this trial and signed informed consent form
Patients who are capable and willing to write subject diary
Patients who agree with maintain same environment during clinical trials

Exclusion:

Nonallergic rhinitis
Severe asthma
Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
Alcohol abuse or Drug abuse
Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives
Patient who administered other investigational products within 30 days
Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons