WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Ketotifen fumarate dry syrup; Drug: WAL801CL dry syrup; Drug: Ketotifen fumarate dry syrup placebo; Drug: WAL 801 CL dry syrup placebo

• Registration Number: NCT02182544
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2001-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• 15 years of age or younger
• Body weight of 14 kg or more
• Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
• "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the observation period
• The Patient Diary can be entered by the patient or parent
• Outpatients

Exclusion Criteria

• Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included

  • Intal® Oral or Inhalation
  • Any eye drops other than Zaditen® Eye Drop
  • External preparations (liniment, poultice)

• Initiation of desensitisation therapy within the past 6 months

• Onset of acute upper respiratory inflammation during the observation period

• Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the disease affects evaluation of the effect of the test drug (*: X-ray examination will be conducted if necessary)

• That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen

• Present or past history of a convulsive disease, such as epilepsy (convulsion threshold values may be decreased by the comparator drug, ketotifen fumarate)

• Clinically significant abnormal changes in laboratory measurements, and thus judgement that the patient is ineligible for inclusion in this study; however, if the patient is judged as falling into Grade 2 or more according to the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study

• Clinically significant renal, hepatic or cardiac disease, or other complications, and thus judgement that the patient is ineligible for inclusion in the study; however, if the patient is judged as falling into Grade 2 or more according to the MHW Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study

• Past history of drug allergy

• 1 month, or 6 times as long as the half life of the investigational drug if it is over 1 month, will not have passed since participation in any other clinical trial study, at the time of the initiation of this study

• Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketotifen fumarate dry syrup + Placebo	Ketotifen fumarate dry syrup	-
WAL801CL dry syrup + Placebo	WAL801CL dry syrup	-
WAL801CL dry syrup + Placebo	Ketotifen fumarate dry syrup placebo	-
Ketotifen fumarate dry syrup + Placebo	WAL 801 CL dry syrup placebo	-

Primary Outcome Measures

Name	Time	Method
Total severity scores of nasal symptoms judged by the physician	2 weeks of first administration of study drug

Secondary Outcome Measures

Name	Time	Method
Nasal symptom score in the diary	2 weeks
Number of patients with abnormal changes from baseline in laboratory tests (hematology, biochemistry, urinalysis)	Baseline and week 2
Total scores for nasal symptoms in the diary	2 weeks of first administration of study drug
Occurrence of adverse events	up to 2 weeks after administration of study drug
Severity score for allergic rhinitis according to the Allergic Rhinitis Severity Classification	2 weeks
Impression of the patient or the parent	week 2 after first administration of study drug
Severity score for each nasal symptom given by the physician	2 weeks of first administration of study drug