Rhinitis
Conditions
Brief summary
Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.
Detailed description
Children, ages 2-11, with a history of perennial allergic rhinitis
Interventions
DRUGDesloratadine (assigned by investigator as part of normal practice)
Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits
Sponsors
Organon and Co
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Children patients of both sexes aged between 2-11 years, of either gender and any race * Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation * Minimum score for inclusion: 10 * Capable of complying with the dosing regimen * Free of any clinically significant disease (other than allergic rhinitis) * Antihistamine must be justified by investigating doctor
Exclusion criteria
* Patients with asthma who require chronic use of inhaled or systemic corticosteroids * History of frequent, clinically significant sinusitis or chronic purulent postnasal drip * Patients with rhinitis medicamentosa * History of hypersensitivity to desloratadine or any of its excipients * Doctor deems unsuitable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Minimum of 7 days after initiation of desloratadine | An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines. |
| General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Minimum of 7 days after initiation of desloratadine | Physicians judged the subjects as good, excellent, fair, or poor. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine | 591 |
| Total | 591 |
Baseline characteristics
| Characteristic | Desloratadine |
|---|---|
| Age, Categorical <=18 years | 591 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 5.28 years STANDARD_DEVIATION 2.92 |
| Region of Enrollment Indonesia | 591 participants |
| Sex/Gender, Customized Female | 238 participants |
| Sex/Gender, Customized Male | 345 participants |
| Sex/Gender, Customized Missing Information for sex | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 591 |
| serious Total, serious adverse events | 0 / 591 |
Outcome results
Primary
Adverse Events
An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.
Time frame: Minimum of 7 days after initiation of desloratadine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine | Adverse Events | Nausea | 3 Participants |
| Desloratadine | Adverse Events | Dizziness | 1 Participants |
Primary
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments
Physicians judged the subjects as good, excellent, fair, or poor.
Time frame: Minimum of 7 days after initiation of desloratadine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine | General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Good | 350 Participants |
| Desloratadine | General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Excellent | 159 Participants |
| Desloratadine | General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Fair | 50 Participants |
| Desloratadine | General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments | Poor | 11 Participants |