Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472) (COMPLETED)
This study has been completed.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00805324
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Asthma
Drug: Desloratadine
Phase III

MedlinePlus related topics: Asthma Hay Fever
Drug Information available for: Descarboethoxyloratadine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate the number of adverse events during the therapy [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: May 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Desloratadine
desloratadine syrup; 5.0 mL once daily for 28 days

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P03472
Study First Received: December 5, 2008
Last Updated: December 5, 2008
ClinicalTrials.gov Identifier: NCT00805324  
Health Authority: Italy: Ministry of Health

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Asthma
Rhinitis
Desloratadine
Histamine
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Loratadine
Rhinitis, Allergic, Seasonal
Lung Diseases
Hypersensitivity, Immediate
Histamine phosphate
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents
Cholinergic Agents
Nose Diseases
Pharmacologic Actions
Histamine Antagonists
Therapeutic Uses
Antipruritics
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009