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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-383 | |||
| 2007_024 |
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Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control | Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters. | 8 weeks (from Week 0 to Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score | Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Satisfaction | At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. | 8 weeks (from Week 0 to Week 8) |
| Physician 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 |
|---|---|---|---|
| 19557208 | Derived | Keith PK, Koch C, Djandji M, Bouchard J, Psaradellis E, Sampalis JS, Schellenberg RR, McIvor RA. Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial). Can Respir J. 2009 May-Jun;16 Suppl A(Suppl A):17A-31A. doi: 10.1155/2009/145071. |
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The anticipated Enrollment was 440, with an expected rate of 20% over the 8-week period, thus 369 patients should complete the study.
First 25 asthmatic patients seen consecutively at each site were invited to participate.
Treatment phase: From the Survey population, blocks of 8 were allowed to participate. All subjects took 1 tablet of montelukast 10 mg once a day at bedtime.
First patient in: APR-02-2007 Last patient out: JAN-25-2008
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients. |
| 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 | Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered "yes" to at least 2 of the 8 asthma control parameters. | 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8. | Posted | Number | Participants | 8 weeks (from Week 0 to Week 8) |
|
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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 | All Patients |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction Not Otherwise Specified | Immune system disorders | MedDRA 10.0 | 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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| 8 weeks (from Week 0 to Week 8) |
| Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale. | 8 weeks (from Week 0 to Week 8) |
At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.
| 8 weeks (from Week 0 to Week 8) |
| Patient Global Allergic Rhinitis Symptoms Assessment | At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms. | 8 weeks (from Week 0 to Week 8) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use | Number | participants |
|
| Allergic Rhinitis Diagnosis Duration | Mean | Standard Deviation | Months |
|
| Asthma Diagnosis Duration | Mean | Standard Deviation | Months |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score | Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score | Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8. | Posted | Mean | Standard Deviation | Units on a Scale | 8 weeks (from Week 0 to Week 8) |
|
|
|
|
| Secondary | Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale. | There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8. | Posted | Mean | Standard Deviation | Units on a Scale | 8 weeks (from Week 0 to Week 8) |
|
|
|
|
| Other Pre-specified | Patient Global Satisfaction | At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. | 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8. | Posted | Number | Participants | 8 weeks (from Week 0 to Week 8) |
|
|
|
|
| Other Pre-specified | Physician Global Satisfaction | At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication. | 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8. | Posted | Number | Participants | 8 weeks (from Week 0 to Week 8) |
|
|
|
|
| Other Pre-specified | Patient Global Allergic Rhinitis Symptoms Assessment | At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms. | 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8. | Posted | Number | Participants | 8 weeks (from Week 0 to Week 8) |
|
|
|
|
| 0 |
| 313 |
| 11 |
| 313 |
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Asthma aggravated | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Muscular pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | 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 |
| Neither satisfied or dissatisfied |
|
| Dissatisfied |
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| Very dissatisfied |
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| Missing |
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| Neither satisfied or dissatisfied |
|
| Dissatisfied |
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| Very dissatisfied |
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| Missing |
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| Bothersome a little of the time |
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| Bothersome some of the time |
|
| Bothersome a good bit of the time |
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| Missing |
|