Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Asthma
• Interventions: Drug: Desloratadine

• Registration Number: NCT00805324
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Children must be >= 6 to < 12 years of age of either sex and any race.

• Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent

• Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations

• Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee

• The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:

  • Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season
  • Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year)

• Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2

• Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma

Exclusion Criteria

• Children who have not observed the designated washout periods for any of the prohibited medications

  • Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR)

• Children with rhinitis medicamentosa

• Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1)

• Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow

• Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids

• Children with a history of hypersensitivity to desloratadine or any of its excipients

• Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety

• A known lack of response to H1-antihistamines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Desloratadine	-

Primary Outcome Measures

Name	Time	Method
Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis	Baseline, Day 8, Day 15, Day 29

Secondary Outcome Measures

Name	Time	Method
To demonstrate that the Global Therapeutic Response is correlated with the degree of improvement of the total nasal/non-nasal symptoms severity score	Day 8, Day 15, Day 29
To evaluate the number of adverse events during the therapy	Day 8, Day 15, and Day 29