- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00805324
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)
February 7, 2022 updated by: Organon and Co
Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
desloratadine syrup; 5.0 mL once daily for 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis
Time Frame: Baseline, Day 8, Day 15, Day 29
|
Baseline, Day 8, Day 15, Day 29
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To demonstrate that the Global Therapeutic Response is correlated with the degree of improvement of the total nasal/non-nasal symptoms severity score
Time Frame: Day 8, Day 15, Day 29
|
Day 8, Day 15, Day 29
|
To evaluate the number of adverse events during the therapy
Time Frame: Day 8, Day 15, and Day 29
|
Day 8, Day 15, and Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
August 1, 2003
Study Completion (Actual)
August 1, 2003
Study Registration Dates
First Submitted
December 5, 2008
First Submitted That Met QC Criteria
December 5, 2008
First Posted (Estimate)
December 9, 2008
Study Record Updates
Last Update Posted (Actual)
February 16, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Asthma
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
Other Study ID Numbers
- P03472
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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