Asthma With Allergic Rhinitis
Conditions
Keywords
Asthma, Allergic rhinitis
Brief summary
Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
Interventions
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
Coadministration of HCP1102 Placebo with HGP0711 for 4-week
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Mean Daytime Nasal Symptom Score | base line, 3-4week(2weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Change of Runny nose (Mean Daytime Nasal Symptom Score) | base line, 1-2week(2weeks), 3-4week(2weeks) |
| Change of Mean Nighttime Nasal Symptom Score | base line, 1-2week(2weeks), 3-4week(2weeks) |
| Change of Mean Daytime Nasal Symptom Score | base line, 1-2week(2weeks), 3-4week(2weeks) |
| Change of sneezing (Mean Daytime Nasal Symptom Score) | base line, 1-2week(2weeks), 3-4week(2weeks) |
| Change of pruritus (Mean Daytime Nasal Symptom Score) | base line, 1-2week(2weeks), 3-4week(2weeks) |
| Change of Mean Composite Symptom Score | base line, 1-2week(2weeks), 3-4week(2weeks) |
Countries
South Korea