Efficacy and Safety of HCP1102 Capsule

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

Official Title
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Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

Conditions
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Asthma With Allergic Rhinitis

Intervention / Treatment
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* Drug: HCP1102+HGP0711Placebo
* Drug: HCP1102Placebo+HGP0711


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCP1102+HGP0711Placebo<br>HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily | Drug: HCP1102+HGP0711Placebo<br>* Coadministration of HCP1102 with HGP0711 Placebo for 4-week<br>|
| Active Comparator: HCP1102Placebo+HGP0711<br>HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily | Drug: HCP1102Placebo+HGP0711<br>* Coadministration of HCP1102 Placebo with HGP0711 for 4-week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mean Daytime Nasal Symptom Score |  | base line, 3-4week(2weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Mean Daytime Nasal Symptom Score |  | base line, 1-2week(2weeks), 3-4week(2weeks) | 
| 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 Composite 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Allergic rhinitis