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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-340 | |||
| 2007_539 |
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This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast | Drug | montelukast 5 mg tablet Once a day (QD) for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization. | 8 Week treatment period initiated at the beginning of a school year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting. | 8 Week treatment period initiated at the beginning of a school year |
| Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants |
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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 |
|---|---|---|---|
| 20674830 | Background | Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1. |
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Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.
Participants were randomized at 165 sites in the US and Canada.
Therapy period: June to November 2006 (including screening period).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks. |
| FG001 | Montelukast 5 mg | Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks. |
| BG001 | Montelukast 5 mg | Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks. |
| 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 | Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization. | The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 8 Week treatment period initiated at the beginning of a school year |
|
Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE tables (566 placebo & 566 montelukast) is the number that received treatment. 16 placebo & 14 montelukast randomized participants did not receive treatment.
Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
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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 | Placebo | Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 9.0 | 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 | ClinicalTrialsDisclosure@merck.com |
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| 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 |
| Drug |
Placebo to montelukast QD for 8 weeks |
|
| 8 Week treatment period initiated at the beginning of a school year |
| Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions. | 8 Week treatment period initiated at the beginning of a school year |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Patient Moved or Relocated |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daytime Asthma Symptom Score | The Participant or parent/guardian scored his/her/child's symptoms [from 0 (best) to 5 (worst)] on a daily basis. Scores were entered into a Participant diary during the 2-week period prior to the start of the study drug. | Mean | Standard Deviation | Units on a Scale |
|
| β-Agonist Use | The number of puffs used per day was entered by the Participant or parent/guardian into a Participant diary during the 2-week period prior to the start of the study drug. | Mean | Standard Deviation | puffs/day |
|
Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks. |
| OG001 | Montelukast 5 mg | Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks. |
|
|
| Secondary | Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting. | The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available. | Posted | Number | Participants | 8 Week treatment period initiated at the beginning of a school year |
|
|
|
| Secondary | Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 8 Week treatment period initiated at the beginning of a school year |
|
|
|
| Secondary | Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions. | The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 8 Week treatment period initiated at the beginning of a school year |
|
|
|
| 1 |
| 566 |
| 189 |
| 566 |
| EG001 | Montelukast 5 mg | Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks. | 4 | 566 | 191 | 566 |
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Lymphangioma | Congenital, familial and genetic disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchitis acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sleep terror | Psychiatric disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nipple pain | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nipple swelling | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nocturnal dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Endodontic procedure | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Wisdom teeth removal | Surgical and medical procedures | MedDRA 9.0 | 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 |