Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis: Double Blinded, Randomized, Placebo Controlled, Parallel Designed, Multi-centered, Phase III Study.

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: CITUS Dry Syrup; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 245
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hodpital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children aged over 24 months and under 15 years.
2. Patients who was diagnosed with perennial allergic rhinitis by ImmunoCAP test.
3. NIS mean total score of 1-week in baseline should be over 4.0.

Exclusion Criteria:

1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as pneumonia, cystic fibrosis, viral influenza, tuberculosis, asthma(status praesens).
2. Patient who has cancer, diabetes mellitus, hypertension, CNS disease, and metabolic disease which need medication.
3. Patient who has rhinitis not caused by allergy.
4. Acute or chronic sinusitis.
5. Patient who has medical history of allergy in seasonal pollen during the trial.
6. Patient who has had eyes or nose surgery within 3 months prior to the trial.
7. Patient who has had eye or upper airway infection within 1 week prior to the treatment period.
8. Beginning immunotherapy or dose of change within 1 month prior to the trial.
9. Patient who has clinical history of sensitivity to allergic rhinitis medication.
10. Patient whose heart function is abnormal: including heart failure, abnormal ECG test value that is clinically significant.
11. Patient who has experience to have participated in other clinical trial within 2 months prior to the trial.
12. Patient who has taken contraindicated medications in this study within 1 week(baseline period) prior to the treatment period.
13. For girl who had her first period, result of pregnancy test was positive.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo dry syrup, b.i.d
Experimental: CITUS Dry Syrup; Pranlukast dry syrup 10%	Drug: CITUS Dry Syrup; Pranlukast 10% dry syrup, b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from baseline in NIS(Nasal Index Score) over the 4-week treatment period	Evaluation : from baseline(1-week prior to treatment)over the 4-week treatment(1-week prior to patients' last visit). NIS : Sum of 4 individual scores for Nasal congestion, Rhinorrhea, Sneezing, and Nasal itching, each rated by patients daily on a 4-point scale [Score 0(best) to 3(worst)].	4 week treatment period (from baseline through the end of week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing improvement of symptom by physician		from baseline through the end of week 4
Assessing improvement of symptom by patient		from baseline through the end of week 4
Mean change of Individual NIS		from baseline through the end of week 4
Ratio distribution of NIS at end of week 4	Percentage of each NIS score.	from baseline through the end of week 4
Cure rate		from baseline through the end of week 4
Cure rate for each symptom		from baseline through the end of week 4
Use of rescue medication		from baseline through the end of week 4
Change of Instantaneous NIS		from baseline through the end of week 4

Collaborators and Investigators

• Sponsor: SamA Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Young Yull Koh, MD, Seoul National University Hospital; Principal Investigator: Bok Yang Pyun, MD, Soonchunhyang University Hospital; Principal Investigator: Jae Won Oh, MD, Hanyang University; Principal Investigator: Yeong Ho Na, MD, KyungHee University Medical Center; Principal Investigator: Soo Jong Hong, MD, Asan Medical Center; Principal Investigator: Hyun Hee Kim, MD, The Catholic University of Korea Bucheon St.Mary's Hospital; Principal Investigator: Dae Hyun Lim, MD, Inha University Hospital; Principal Investigator: Kang Mo Ahn, MD, Samsung Medical Center; Principal Investigator: Myung Hyun Sohn, MD, Severance Hospital; Principal Investigator: Jin Tack Kim, MD, The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: February 6, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2012
• Last Update Submitted That Met QC Criteria: February 26, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: CITUS_P3