Seasonal Allergic Rhinitis
Conditions
Brief summary
This study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.
Interventions
DRUGmontelukast sodium
one montelukast chewable tablet daily at bed time for 2 weeks, 4 mg for patients aged 2-5 years and 5 mg for patients 6-14 years
DRUGComparator: Placebo
one placebo chewable tablet daily at bed time for 2 weeks
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Patient has a history of allergic rhinitis symptoms which flare up during the study season * Patient is a non-smoker * Patient is in otherwise good health * Patient is able to chew a tablet
Exclusion criteria
* Patient is hospitalized * Patient is pregnant or nursing mother, or \<8 weeks post partum * Patient and/or parent intend to move or vacation away from home during the trial * Patient has had a major surgical procedure within 4 weeks of the prestudy visit * Patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study * Patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study * Patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAEs) | 2 weeks | A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Drug-related CAEs | 2 weeks | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs |
| Number of Patients Who Were Discontinued Due to CAEs | 2 weeks | — |
| Number of Patients With Laboratory Adverse Experiences (LAEs) | 2 weeks | A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Patients With Serious CAEs | 2 weeks | Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
| Number of Patients With Drug-related LAEs | 2 weeks | — |
| Number of Patients Who Were Discontinued Due to LAEs | 2 weeks | — |
| Number of Patients With Serious LAEs | 2 weeks | Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose |
Participant flow
Recruitment details
Thirty one study sites in the United States. Prime Therapy Period: Mar-2001 to Jun-2001.
Pre-assignment details
Patients who required excluded medication and those who did not meet a minimum predefined level of combined daytime rhinitis symptoms score during the run-in period were excluded from randomization.
Participants by arm
| Arm | Count |
|---|---|
| Montelukast 4 mg and 5 mg Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks. | 280 |
| Placebo Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. | 133 |
| Total | 413 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Lack of Efficacy | 0 | 4 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 4 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Montelukast 4 mg and 5 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 7.9 years STANDARD_DEVIATION 3.7 | 8.4 years STANDARD_DEVIATION 3.8 | 8.0 years STANDARD_DEVIATION 3.7 |
| Sex/Gender, Customized Boys | 157 participants | 77 participants | 234 participants |
| Sex/Gender, Customized Girls | 123 participants | 56 participants | 179 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 73 / 280 | 35 / 133 |
| serious Total, serious adverse events | 1 / 280 | 0 / 133 |
Outcome results
Primary
Number of Patients With Clinical Adverse Experiences (CAEs)
A clinical adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 73 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 207 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | With CAEs | 35 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAEs) | Without CAEs | 98 Participants |
Secondary
Number of Patients Who Were Discontinued Due to CAEs
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients Who Were Discontinued Due to CAEs | Discontinued Due to CAEs | 5 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients Who Were Discontinued Due to CAEs | Did Not Discontinue Due to CAEs | 275 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to CAEs | Discontinued Due to CAEs | 1 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to CAEs | Did Not Discontinue Due to CAEs | 132 Participants |
Secondary
Number of Patients Who Were Discontinued Due to LAEs
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients Who Were Discontinued Due to LAEs | Did Not Discontinue Due to LAEs | 272 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients Who Were Discontinued Due to LAEs | Discontinued Due to LAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to LAEs | Did Not Discontinue Due to LAEs | 129 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to LAEs | Discontinued Due to LAEs | 0 Participants |
Secondary
Number of Patients With Drug-related CAEs
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Drug-related CAEs | With Drug-related CAEs | 10 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Drug-related CAEs | Without Drug-related CAEs | 270 Participants |
| Placebo | Number of Patients With Drug-related CAEs | With Drug-related CAEs | 5 Participants |
| Placebo | Number of Patients With Drug-related CAEs | Without Drug-related CAEs | 128 Participants |
Secondary
Number of Patients With Drug-related LAEs
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Drug-related LAEs | With Drug-related LAEs | 1 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Drug-related LAEs | Without Drug-related LAEs | 271 Participants |
| Placebo | Number of Patients With Drug-related LAEs | With Drug-related LAEs | 2 Participants |
| Placebo | Number of Patients With Drug-related LAEs | Without Drug-related LAEs | 127 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs)
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 2 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 270 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | With LAEs | 3 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) | Without LAEs | 126 Participants |
Secondary
Number of Patients With Serious CAEs
Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Serious CAEs | With Serious CAEs | 1 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Serious CAEs | Without Serious CAEs | 279 Participants |
| Placebo | Number of Patients With Serious CAEs | With Serious CAEs | 0 Participants |
| Placebo | Number of Patients With Serious CAEs | Without Serious CAEs | 133 Participants |
Secondary
Number of Patients With Serious LAEs
Serious LAEs are any LAEs occurring at any dose that: Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time frame: 2 weeks
Population: All patients who took study medication during the 2-week, double-blind treatment period and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast 4 mg and 5 mg | Number of Patients With Serious LAEs | With Serious LAEs | 0 Participants |
| Montelukast 4 mg and 5 mg | Number of Patients With Serious LAEs | Without Serious LAEs | 272 Participants |
| Placebo | Number of Patients With Serious LAEs | With Serious LAEs | 0 Participants |
| Placebo | Number of Patients With Serious LAEs | Without Serious LAEs | 129 Participants |