Asthma
Conditions
Brief summary
A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.
Interventions
DRUGmontelukast sodium
one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
DRUGComparator: Placebo
one chewable placebo tablet, once daily at bedtime for 12 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 5 Years
Healthy volunteers
No
Inclusion criteria
* Patient has history of physician diagnosed asthma * Patient is in otherwise good stable health * Patient is able to chew a tablet
Exclusion criteria
* Patient is hospitalized * Patient and/or parent of guardian intends to move or vacation away from home during the course of the study * Patient had any major surgical procedure within 4 weeks before the study * Patient had active sinus disease within 3 weeks before the study * Patient had required intubation for asthma in the past * Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study * Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | 12 weeks of treatment | An 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 Serious CAEs Reported by Patients - Base Study | 12 weeks of treatment | 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 Serious Drug-related CAEs Reported by Patients - Base Study | 12 weeks of treatment | Patients who reported serious drug-related CAEs during 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to CAEs - Base Study | 12 weeks of treatment | Patients who were discontinued due to CAEs during 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | 12 weeks of treatment | Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | 12 weeks of treatment | Patients who were discontinued due to serious CAEs during 12 weeks of treatment |
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | 12 weeks of treatment | 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 Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | 12 weeks of treatment | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs |
| Number of Patients Who Were Discontinued Due to LAEs - Base Study | 12 weeks of treatment | Patients who were discontinued due to LAEs during 12 weeks of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | 12 weeks of treatment | Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment |
| Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | up to 2.8 years | An 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 |
| Number of Patients With Drug-related CAEs Reported by Patients - Extension | up to 2.8 years | 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 With Serious CAEs Reported by Patients - Extension | up to 2.8 years | 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 CAEs Reported by Patients - Base Study | 12 weeks of treatment | 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 - Extension | up to 2.8 years | Patients who were discontinued due to CAEs up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | up to 2.8 years | Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | up to 2.8 years | Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | up to 2.8 years | Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment |
| Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | up to 2.8 years | 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 Drug-related Laboratory Adverse Experiences (LAEs) - Extension | up to 2.8 years | Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs |
| Number of Patients With Serious LAEs - Extension | up to 2.8 years | 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 |
| Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | up to 2.8 years | Patients who reported serious drug-related LAEs up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to LAEs - Extension | up to 2.8 years | Patients who were discontinued due to LAEs up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | up to 2.8 years | Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | up to 2.8 years | Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment |
| Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | up to 2.8 years | Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment |
| Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | up to 2.8 years | Patients who reported serious drug-related CAEs up to 2.8 years of treatment |
Participant flow
Recruitment details
Base Study: 93 sites in the United States (US) and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Dec-1997 to Mar-1999. Extension Study: 75 sites in the US and other countries in Africa, Australia, Europe, North America, and South America. Therapy period: Mar-1998 to Mar-2001.
Pre-assignment details
Base Study: Patients who required excluded medication and those who did not meet a minimum predefined level of asthma symptoms and β-agonist use during run-in (Period I) were excluded from randomization (Period II). Extension Study (Period III): Patients who did not complete Visit 9 of Base Study were not eligible for the optional Extension.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks. | 228 |
| Montelukast Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks. | 461 |
| Total | 689 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Base Study - (Period II) | Adverse Event | 8 | 0 | 16 |
| Base Study - (Period II) | Lack of Efficacy | 0 | 0 | 1 |
| Base Study - (Period II) | Lost to Follow-up | 2 | 0 | 7 |
| Base Study - (Period II) | Protocol Violation | 12 | 0 | 12 |
| Base Study - (Period II) | Site Error | 0 | 0 | 1 |
| Base Study - (Period II) | Withdrawal by Subject | 4 | 0 | 8 |
| Extension Study - (Period III) | Adverse Event | 0 | 5 | 22 |
| Extension Study - (Period III) | Lost to Follow-up | 0 | 7 | 13 |
| Extension Study - (Period III) | Noncompliance | 0 | 0 | 3 |
| Extension Study - (Period III) | Other | 0 | 0 | 2 |
| Extension Study - (Period III) | Patient Relocated | 0 | 1 | 1 |
| Extension Study - (Period III) | Protocol Violation | 0 | 17 | 14 |
| Extension Study - (Period III) | Study Terminated for Admin Reasons | 0 | 74 | 185 |
| Extension Study - (Period III) | Withdrawal by Subject | 0 | 20 | 40 |
Baseline characteristics
| Characteristic | Placebo | Montelukast | Total |
|---|---|---|---|
| Age, Continuous | 3.62 years STANDARD_DEVIATION 1.1 | 3.58 years STANDARD_DEVIATION 1.11 | 3.59 years STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 97 Participants | 189 Participants | 286 Participants |
| Sex: Female, Male Male | 131 Participants | 272 Participants | 403 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 188 / 228 | 148 / 157 | 435 / 461 |
| serious Total, serious adverse events | 9 / 228 | 15 / 157 | 56 / 461 |
Outcome results
Primary
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
An 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: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | With CAEs | 202 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | Without CAEs | 26 Participants |
| Montelukast | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | With CAEs | 406 Participants |
| Montelukast | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study | Without CAEs | 55 Participants |
Secondary
Number of Patients Who Were Discontinued Due to CAEs - Base Study
Patients who were discontinued due to CAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to CAEs - Base Study | Discontinued Due to CAEs | 7 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to CAEs - Base Study | Did Not Discontinue Due to CAEs | 221 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to CAEs - Base Study | Discontinued Due to CAEs | 16 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to CAEs - Base Study | Did Not Discontinue Due to CAEs | 445 Participants |
Secondary
Number of Patients Who Were Discontinued Due to CAEs - Extension
Patients who were discontinued due to CAEs up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to CAEs - Extension | Discontinued Due to CAEs | 5 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to CAEs - Extension | Did Not Discontinue Due to CAEs | 152 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to CAEs - Extension | Discontinued Due to CAEs | 18 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to CAEs - Extension | Did Not Discontinue Due to CAEs | 346 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Discontinued Due to Drug-related CAEs | 1 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Did Not Discontinue Due to Drug-related CAEs | 227 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Discontinued Due to Drug-related CAEs | 2 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study | Did Not Discontinue Due to Drug-related CAEs | 459 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Discontinued Due to Drug-related CAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Did Not Discontinue Due to Drug-related CAEs | 157 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Discontinued Due to Drug-related CAEs | 2 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension | Did Not Discontinue Due to Drug-related CAEs | 362 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Discontinued Due to Drug-related LAEs | 1 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Did Not Discontinue Due to Drug-related LAEs | 223 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Discontinued Due to Drug-related LAEs | 0 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study | Did Not Discontinue Due to Drug-related LAEs | 451 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Discontinued Due to Drug-related LAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Did Not Discontinue Due to Drug-related LAEs | 154 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Discontinued Due to Drug-related LAEs | 4 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension | Did Not Discontinue Due to Drug-related LAEs | 353 Participants |
Secondary
Number of Patients Who Were Discontinued Due to LAEs - Base Study
Patients who were discontinued due to LAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to LAEs - Base Study | Discontinued Due to LAEs | 1 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to LAEs - Base Study | Did Not Discontinue Due to LAEs | 223 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to LAEs - Base Study | Discontinued Due to LAEs | 0 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to LAEs - Base Study | Did Not Discontinue Due to LAEs | 451 Participants |
Secondary
Number of Patients Who Were Discontinued Due to LAEs - Extension
Patients who were discontinued due to LAEs up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to LAEs - Extension | Discontinued Due to LAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to LAEs - Extension | Did Not Discontinue Due to LAEs | 154 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to LAEs - Extension | Discontinued Due to LAEs | 4 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to LAEs - Extension | Did Not Discontinue Due to LAEs | 353 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
Patients who were discontinued due to serious CAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Discontinued Due to Serious CAEs | 2 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Did Not Discontinue Due to Serious CAEs | 226 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Discontinued Due to Serious CAEs | 8 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study | Did Not Discontinue Due to Serious CAEs | 453 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Discontinued Due to Serious CAEs | 1 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Did Not Discontinue Due to Serious CAEs | 156 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Discontinued Due to Serious CAEs | 9 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious CAEs - Extension | Did Not Discontinue Due to Serious CAEs | 355 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Discontinued Due to Serious Drug-related CAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Not Discontinued Due to Serious Drug-related CAEs | 157 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Discontinued Due to Serious Drug-related CAEs | 1 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension | Not Discontinued Due to Serious Drug-related CAEs | 363 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Not Discontinued Due to Serious Drug-related LAEs | 154 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Discontinued Due to Serious Drug-related LAEs | 0 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Not Discontinued Due to Serious Drug-related LAEs | 356 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension | Discontinued Due to Serious Drug-related LAEs | 1 Participants |
Secondary
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Discontinued Due to Serious LAEs | 0 Participants |
| Placebo | Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Did Not Discontinue Due to Serious LAEs | 154 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Discontinued Due to Serious LAEs | 1 Participants |
| Montelukast | Number of Patients Who Were Discontinued Due to Serious LAEs - Extension | Did Not Discontinue Due to Serious LAEs | 356 Participants |
Secondary
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
An 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: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | With CAE | 149 Participants |
| Placebo | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | Without CAE | 8 Participants |
| Montelukast | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | With CAE | 353 Participants |
| Montelukast | Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension | Without CAE | 11 Participants |
Secondary
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.~Drug relationship for 1 patient in the Placebo group should have been listed as definitely not drug related.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related CAEs Reported by Patients - Base Study | With Drug-Related CAEs | 9 Participants |
| Placebo | Number of Patients With Drug-related CAEs Reported by Patients - Base Study | Without Drug-Related CAEs | 219 Participants |
| Montelukast | Number of Patients With Drug-related CAEs Reported by Patients - Base Study | With Drug-Related CAEs | 19 Participants |
| Montelukast | Number of Patients With Drug-related CAEs Reported by Patients - Base Study | Without Drug-Related CAEs | 442 Participants |
Secondary
Number of Patients With Drug-related CAEs Reported by Patients - Extension
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related CAEs Reported by Patients - Extension | With Drug-related CAEs | 2 Participants |
| Placebo | Number of Patients With Drug-related CAEs Reported by Patients - Extension | Without Drug-related CAEs | 155 Participants |
| Montelukast | Number of Patients With Drug-related CAEs Reported by Patients - Extension | With Drug-related CAEs | 14 Participants |
| Montelukast | Number of Patients With Drug-related CAEs Reported by Patients - Extension | Without Drug-related CAEs | 350 Participants |
Secondary
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: 12 weeks of treatment
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | With Drug-Related LAEs | 1 Participants |
| Placebo | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | Without Drug-Related LAEs | 223 Participants |
| Montelukast | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | With Drug-Related LAEs | 7 Participants |
| Montelukast | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study | Without Drug-Related LAEs | 444 Participants |
Secondary
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | With Drug-related LAEs | 0 Participants |
| Placebo | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Without Drug-related LAEs | 154 Participants |
| Montelukast | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | With Drug-related LAEs | 7 Participants |
| Montelukast | Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Without Drug-related LAEs | 350 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
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: 12 weeks of treatment
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | With LAEs | 12 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | Without LAEs | 212 Participants |
| Montelukast | Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | With LAEs | 16 Participants |
| Montelukast | Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study | Without LAEs | 435 Participants |
Secondary
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
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: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | With LAEs | 14 Participants |
| Placebo | Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | Without LAEs | 140 Participants |
| Montelukast | Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | With LAEs | 42 Participants |
| Montelukast | Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension | Without LAEs | 315 Participants |
Secondary
Number of Patients With Serious CAEs Reported by Patients - Base Study
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: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.~A serious CAE (study drug overdose) prior to randomization in the Placebo group is not included in this number
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious CAEs Reported by Patients - Base Study | With Serious CAEs | 9 Participants |
| Placebo | Number of Patients With Serious CAEs Reported by Patients - Base Study | Without Serious CAEs | 219 Participants |
| Montelukast | Number of Patients With Serious CAEs Reported by Patients - Base Study | With Serious CAEs | 17 Participants |
| Montelukast | Number of Patients With Serious CAEs Reported by Patients - Base Study | Without Serious CAEs | 444 Participants |
Secondary
Number of Patients With Serious CAEs Reported by Patients - Extension
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: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious CAEs Reported by Patients - Extension | With Serious CAEs | 15 Participants |
| Placebo | Number of Patients With Serious CAEs Reported by Patients - Extension | Without Serious CAEs | 142 Participants |
| Montelukast | Number of Patients With Serious CAEs Reported by Patients - Extension | With Serious CAEs | 38 Participants |
| Montelukast | Number of Patients With Serious CAEs Reported by Patients - Extension | Without Serious CAEs | 326 Participants |
Secondary
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
Patients who reported serious drug-related CAEs during 12 weeks of treatment
Time frame: 12 weeks of treatment
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | With Serious Drug-related CAEs | 0 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | Without Serious Drug-related CAEs | 228 Participants |
| Montelukast | Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | With Serious Drug-related CAEs | 2 Participants |
| Montelukast | Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study | Without Serious Drug-related CAEs | 459 Participants |
Secondary
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
Patients who reported serious drug-related CAEs up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | With Serious Drug-related CAEs | 0 Participants |
| Placebo | Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | Without Serious Drug-related CAEs | 157 Participants |
| Montelukast | Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | With Serious Drug-related CAEs | 4 Participants |
| Montelukast | Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension | Without Serious Drug-related CAEs | 360 Participants |
Secondary
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
Patients who reported serious drug-related LAEs up to 2.8 years of treatment
Time frame: up to 2.8 years
Population: All patients who took study medication and had at least one laboratory test post baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | With Serious Drug-Related LAEs | 0 Participants |
| Placebo | Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Without Serious Drug-Related LAEs | 154 Participants |
| Montelukast | Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | With Serious Drug-Related LAEs | 1 Participants |
| Montelukast | Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension | Without Serious Drug-Related LAEs | 356 Participants |
Secondary
Number of Patients With Serious LAEs - Extension
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: up to 2.8 years
Population: All patients who took study medication and had any laboratory tests performed were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients With Serious LAEs - Extension | With Serious LAEs | 0 Participants |
| Placebo | Number of Patients With Serious LAEs - Extension | Without Serious LAEs | 154 Participants |
| Montelukast | Number of Patients With Serious LAEs - Extension | With Serious LAEs | 1 Participants |
| Montelukast | Number of Patients With Serious LAEs - Extension | Without Serious LAEs | 356 Participants |