Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Urticaria
Conditions
Brief summary
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The participants will take desloratadine syrup for 14 days. At the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. Effectiveness will also be rated at the end of treatment.
Detailed description
Physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.
Interventions
DRUGDesloratadine Syrup
Desloratadine (Aerius) Syrup; Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days: * Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg \[milligrams\] of desloratadine) * Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine) * Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)
Sponsors
Organon and Co
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 11 Years
Healthy volunteers
No
Inclusion criteria
* Outpatient pediatric participants, male or female, aged 6 months to 11 years * Diagnosis of allergic rhinitis or chronic idiopathic urticaria
Exclusion criteria
* Known hypersensitivity to desloratadine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events Reported By Category After 14 Days of Treatment | 15 Days | Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. |
| Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | 15 Days | Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity. |
| Participant Global Tolerability Assessment | Day 15 | The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows: * Excellent * Very Good * Good * Fair * poor Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Assessment of Clinical Efficacy | Day 15 | Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15. |
Participant flow
Pre-assignment details
The total number of participants enrolled was 2980. A total of 2978 participants received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Desloratadine (Aerius) Syrup Pediatric participants with a diagnosis of allergic rhinitis or chronic idiopathic urticaria received Desloratadine (Aerius) Syrup. Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
* Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg \[milligrams\] of desloratadine)
* Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
* Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine) | 2,978 |
| Total | 2,978 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Poor Compliance | 8 |
| Overall Study | Unknown reason | 2 |
Baseline characteristics
| Characteristic | Desloratadine (Aerius) Syrup |
|---|---|
| Age, Continuous | 5.74 years STANDARD_DEVIATION 3.272 |
| Sex/Gender, Customized Female | 1457 Participants |
| Sex/Gender, Customized Male | 1511 Participants |
| Sex/Gender, Customized Missing Data | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,978 |
| serious Total, serious adverse events | 1 / 2,978 |
Outcome results
Primary
Number of Adverse Events Reported By Category After 14 Days of Treatment
Safety was assessed by determining the incidence of all Adverse Events (AE) which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Total number of AEs reported were presented in several categories. Classification, causality & intensity for AEs were determined by investigator after obtaining sufficient information. A Serious Adverse Event (SAE) was any adverse drug experience that resulted in: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Time frame: 15 Days
Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Total Number of AEs | 26 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Mild AEs | 21 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Moderate AEs | 4 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Severe AEs | 1 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Treatment-related AEs | 20 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Mild Treatment-related AEs | 19 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Moderate Treatment-related AEs | 0 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Severe Treatment-related AEs | 1 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of SAEs | 1 Adverse Events |
| Desloratadine (Aerius) Syrup | Number of Adverse Events Reported By Category After 14 Days of Treatment | Number of Treatment-related SAEs | 0 Adverse Events |
Primary
Participant Global Tolerability Assessment
The participant's global assessment of tolerability with the medication was assessed using a categorical scale as follows: * Excellent * Very Good * Good * Fair * poor Parent or guardian of each participant followed up for a final visit after 14 days (Day 15) at which tolerability was rated and reported for entire treatment period. Number of participants in each category is presented.
Time frame: Day 15
Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup (N=2978). For 31 participants, tolerability was not assessed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine (Aerius) Syrup | Participant Global Tolerability Assessment | Excellent | 1278 Participants |
| Desloratadine (Aerius) Syrup | Participant Global Tolerability Assessment | Very Good | 1339 Participants |
| Desloratadine (Aerius) Syrup | Participant Global Tolerability Assessment | Good | 307 Participants |
| Desloratadine (Aerius) Syrup | Participant Global Tolerability Assessment | Fair | 15 Participants |
| Desloratadine (Aerius) Syrup | Participant Global Tolerability Assessment | Poor | 8 Participants |
Primary
Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment
Safety was assessed by determining the incidence of all AEs which occurred between Baseline Visit (Day 1) & Final Visit (Day 15) & were recorded in Case Report Forms. Number of participants experiencing AEs were presented in several categories. Some AEs lead to discontinuation (d/c). Classification, causality & intensity for AEs were determined by investigator. A SAE was any adverse drug experience that resulted in any of the following: death; life-threatening condition; inpatient hospitalization/prolongation of existing hospitalization; persistent or significant disability/incapacity.
Time frame: 15 Days
Population: The Safety population included all participants who had taken at least one dose of Desloratadine Syrup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with AEs | 24 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with Mild AEs | 21 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with Moderate AEs | 2 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with Severe AEs | 1 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with Treatment-related AEs | 20 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with AEs - Temporary d/c | 1 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with AEs - Permanent d/c | 2 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with AEs - Withdrawal | 2 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with SAEs | 1 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants with Treatment-related SAEs | 0 Participants |
| Desloratadine (Aerius) Syrup | Safety of Desloratadine Syrup Reported by Number of Participants Experiencing Adverse Events After 14 Days of Treatment | Number of Participants Who Died Due to AEs | 0 Participants |
Secondary
Investigator Assessment of Clinical Efficacy
Investigator assessment of clinical efficacy of Desloratadine Syrup in relieving participants' symptoms of either allergic rhinitis or chronic idiopathic urticaria at final visit (Day 15). The number of participants categorized by investigator as: improved, no improvement, or worsened was reported at Day 15.
Time frame: Day 15
Population: ITT Population, which consisted of all participants who had taken at least one dose of Desloratadine Syrup and had a post baseline clinical efficacy assessment (N=2956). For 4 participants, a clinical efficacy assessment was not reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Desloratadine (Aerius) Syrup | Investigator Assessment of Clinical Efficacy | Improvement | 2913 Participants |
| Desloratadine (Aerius) Syrup | Investigator Assessment of Clinical Efficacy | No Improvement | 39 Participants |
| Desloratadine (Aerius) Syrup | Investigator Assessment of Clinical Efficacy | Worsened | 0 Participants |