Phase IV Clinical Trial to Evaluate in Children with Symptom Contral due to Persistent Allergic Rhinitis

A Multicenter, Randomized, Active-controlled, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Asthmon?(Montelukast) in Children with Symptom Control due to Persistent Allergic Rhinitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000972

Enrollment

100

Registered

2013-12-31

Start date

2013-09-28

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : ASTHMON : Once a day 5mg(chewable) Chew_4 weeks SERENZAL : Once a day 5mg (as liquid 10ml) oral administration (at bedtime) _4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Persistent Nasal symptom for more than 4 days and 4 weeks per week or more , and the duration and specificity of immunoglobulin-positive test results identified children with persistent allergic rhinitis 2. Randomized at baseline TNSS score of the previous three days more than the average of 3 points 3. Subjects and subjects representative(guardian) to participate in this clinical trial voluntarily provided written informed consent, and if consent

Exclusion criteria

Exclusion criteria: 1. Within 2 weeks before screening Otolaryngology ever experienced patients infected 2. Steroid therapy, and patients with asthma who need 3. During clinical trials, systemic steroids or antihistamines necessary medical treatment and patients with the skin disease

Design outcomes

Primary

Measure	Time frame
Change in TNSS(Total Nasal Symptom Score)	—

Secondary

Measure	Time frame
Change in TNSS(Total Nasal Symptom Score);Change in TFSS(Total Four Symptom Score)	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Ho Rha

Kyung Hee University Hospital

Outcome results