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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_003 |
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The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Experimental | Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
|
| Inhaled Corticosteroids (ICS) | Active Comparator | Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Daytime Asthma Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline for Daily Allergic Rhinitis Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | Baseline and Week 12 |
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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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Up to 1 week for wash-out - prior to baseline randomization.
Conducted at 5 sites in Korea, Jan2005~ Oct2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast | Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| FG001 | Inhaled Corticosteroids (ICS) | Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast | Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. |
| 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 | Change From Baseline for Daytime Asthma Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Posted | Mean | Standard Deviation | Units on scale | Baseline and Week 12 |
|
Up to 12 months
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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 | Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| 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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| inhaled corticosteroid | Drug | Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months |
|
| Withdrawal by Subject |
|
| BG001 | Inhaled Corticosteroids (ICS) | Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Count of Participants | Participants |
|
| Allergic rhinitis | Based on GINA guidelines. The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Number | participants |
|
| Type of allergic rhinitis | The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Number | Participants |
|
| Daily allergic rhinitis symptom score | The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). 24 participants with baseline scores were included in the Montelukast group and 28 participants with baseline scores were included in the ICS group. | Mean | Standard Deviation | Units on scale |
|
| Daytime asthma symptom score | The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Mean | Standard Deviation | Units on scale |
|
| Duration of allergic rhinitis | 24 participants were included in the Montelukast group and 28 participants were included in the ICS group. | Mean | Standard Deviation | Years |
|
| Duration of asthma | The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included. | Mean | Standard Deviation | Years |
|
| OG001 | Daytime Asthma Symptom Score at 12 Weeks - Montelukast | Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| OG002 | Daytime Asthma Symptom Score at Baseline - ICS | Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
| OG003 | Daytime Asthma Symptom Score at 12 Weeks - ICS | Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. |
|
|
|
| Secondary | Change From Baseline for Daily Allergic Rhinitis Symptom Score | The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome. | The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included. | Posted | Mean | Standard Deviation | Units on scale | Baseline and Week 12 |
|
|
|
|
| 4 |
| 100 |
| 83 |
| 100 |
| EG001 | Inhaled Corticosteroids (ICS) | Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. | 3 | 91 | 70 | 91 |
| PYREXIA | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| CHRONIC SINUSITIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| SNEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| UPPER AIRWAY OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | 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 |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
|
Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores. |
| t-test, 2 sided |
| 0.032 |
| Mean Difference (Final Values) |
| -0.12 |
| 2-Sided |
| 95 |
| -0.24 |
| -0.01 |
| Superiority or Other (legacy) |