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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-302 | |||
| 2006_015 |
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This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: drug + episodic supplemental placebo | Active Comparator | Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period |
|
| Arm 2: placebo comparator + episodic supplemental drug | Active Comparator | Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period |
|
| Arm 3: placebo comparator + episodic supplemental placebo | Placebo Comparator | Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period | The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems. | 1-year treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21624752 | Result | Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4. |
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1979 screened; 208 excluded.
Randomized patients met the following criteria: age 6-71 months, a history of episodic asthma symptoms that ranged between 2 and 6 episodes, depending on age, that were separated in time by periods without asthma symptoms. Patients had at least 1 corticosteroid treatment or were hospitalized for asthma at least 1 time.
Patients were recruited from 111 centers worldwide.
Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006.
The last patient's last visit was completed on 12-Aug-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daily Montelukast | Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| FG001 | Intermittent Montelukast | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| FG002 | Placebo | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Montelukast | Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period | The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems. | Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population. | Posted | Mean | 95% Confidence Interval | Asthma attacks within episodes per year | 1-year treatment period |
|
October 2006 through August 2009
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daily Montelukast | Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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|
| Comparator: Placebo (unspecified) | Drug | Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period. |
|
| montelukast sodium | Drug | Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period. |
|
|
| 1 Year |
| Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes. | 1 Year |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Progressive Disease |
|
| Trial Terminated |
|
| BG001 | Intermittent Montelukast | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| BG002 | Placebo | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| OG001 | Intermittent Montelukast | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
| OG002 | Placebo | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. |
|
|
|
| Secondary | Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes. | Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | 1 Year |
|
|
|
|
| Secondary | Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes | Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes. | Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | 1 Year |
|
|
|
|
| 28 |
| 584 |
| 481 |
| 584 |
| EG001 | Intermittent Montelukast | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. | 41 | 588 | 506 | 588 |
| EG002 | Placebo | Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period. | 33 | 585 | 486 | 585 |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Adenoiditis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hepatitis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Kawasaki's disease | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Laryngotracheitis obstructive | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Parotid abscess | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pneumonia viral | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Viral diarrhoea | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Superiority or Other (legacy) |
| The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. | ANOVA | An ANOVA model containing factors for treatment, age group, and geographical region was used. | 0.202 | Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg's method. | Least-Squares Mean Difference | -0.17 | Standard Error of the Mean | 0.14 | 95 | -0.44 | 0.09 | Superiority or Other (legacy) |
| Superiority or Other (legacy) |
| The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. | ANOVA | An ANOVA model containing factors for treatment, age group, and geographical region was used. | 0.061 | Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg's method. | Least-Squares Mean Difference | -0.11 | Standard Error of the Mean | 0.06 | 95 | -0.23 | 0.00 | Superiority or Other (legacy) |