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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-385 | |||
| 2009_523 |
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a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 4-5 mg for 12 weeks, oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | Week 0, 4, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | Week 0, 4, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Satisfaction | At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients. | week 0, 4, 8 and 12 |
| Patient Global Satisfaction |
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 |
|---|---|---|---|
| 24932181 | Result | Berube D, Djandji M, Sampalis JS, Becker A. Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study. Allergy Asthma Clin Immunol. 2014 May 6;10(1):21. doi: 10.1186/1710-1492-10-21. eCollection 2014. |
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First patient in: JUN-19-2006
Last patient out: OCT-28-2008
Total number of sites: 37 sites in Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast | Montelukast 4-5 mg for 12 weeks, oral tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast | Montelukast 4-5 mg for 12 weeks, oral tablet |
| 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 | Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12. | Posted | Number | Participants | Week 0, 4, and 12 |
|
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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 | Montelukast | Montelukast 4-5 mg for 12 weeks, oral tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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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 |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
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At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. |
| Week 0, 4, 8 and 12 |
| Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described. | Weeks 4, 8, and 12 |
| Withdrawal by Subject |
|
| Screening Failure |
|
| Stopped Medication |
|
| Parent misunderstood study |
|
| Parent dissatisfied |
|
| No improvement |
|
| Patient moved |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ICS (Inhaled Corticosteroids) Use | Number | Participants |
|
| Asthma Diagnosis Duration | Mean | Standard Deviation | Months |
|
ITT population, receiving montelukast 4 or 5 mg/day |
| OG002 | Montelukast ITT at Week 12 | ITT population, receiving montelukast 4 or 5 mg/day |
|
|
|
| Secondary | Asthma Control Questionnaire (ACQ) | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. | 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12. | Posted | Number | Participants | Week 0, 4, and 12 |
|
|
|
| Other Pre-specified | Physician Global Satisfaction | At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients. | 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12. | Posted | Number | Participants | week 0, 4, 8 and 12 |
|
|
|
|
| Other Pre-specified | Patient Global Satisfaction | At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. | 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12. | Posted | Number | Participants | Week 0, 4, 8 and 12 |
|
|
|
|
| Other Pre-specified | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described. | 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12. | Posted | Mean | Standard Deviation | Units on a Scale | Weeks 4, 8, and 12 |
|
|
|
|
| 5 |
| 146 |
| Pneumomia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | 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 |
| D012959 |
| Socioeconomic Factors |
|
| Tapered and Not well controlled |
|
| Tapered and Well controlled |
|
| Missing |
|
| Satisfied |
|
| Neither Satisfied or Dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Missing |
|
The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8. |
| <0.001 |
| 95 |
| Superiority or Other (legacy) |
| Satisfied |
|
| Neither Satisfied or Dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Missing |
|