Rhinitis, Urticaria
Conditions
Brief summary
The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.
Detailed description
Pediatric patients aged 1-5 years
Interventions
DRUGDesloratadine
2.5 ml (1.25 mg) once daily
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Patients with allergic rhinitis or chronic idiopathic urticaria * Aged 1-5 years old * Caregiver's consent to participate
Exclusion criteria
* Healthy individuals * Younger or older than the 1-5 year old age range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Adverse Events | Follow-up visit at 3 - 5 weeks after treatment initiation | An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aerius® Syrup Aerius® (SCH 34117, desloratadine, DL) syrup administered to those with allergic rhinitis or chronic idiopathic urticaria | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Aerius® Syrup |
|---|---|
| Age, Continuous | 3.1 years STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 100 |
| serious Total, serious adverse events | 1 / 100 |
Outcome results
Primary
Proportion of Patients With Adverse Events
An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions.
Time frame: Follow-up visit at 3 - 5 weeks after treatment initiation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aerius® Syrup | Proportion of Patients With Adverse Events | Gastrointestinal Disorders | 20 participants |
| Aerius® Syrup | Proportion of Patients With Adverse Events | General Disorders & Administration Site Conditions | 4 participants |
| Aerius® Syrup | Proportion of Patients With Adverse Events | Infections and Infestations | 21 participants |
| Aerius® Syrup | Proportion of Patients With Adverse Events | Respiratory, Thoracic, and Mediastinal Disorders | 6 participants |
| Aerius® Syrup | Proportion of Patients With Adverse Events | Skin and Subcutaneous Tissue Disorders | 4 participants |