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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_596 |
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This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast + Beclomethasone |
|
| 2 | Experimental | Montelukast + Placebo inhaler |
|
| 3 | Experimental | Placebo tablet + Beclomethasone |
|
| 4 | Placebo Comparator | Placebo tablet + Placebo inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | 10 mg tablet taken once daily at bedtime for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma | Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups | Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups |
| Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma | The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use | Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
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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 |
|---|---|---|---|
| 10588598 | Result | Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042. |
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Patients received inhaled beclomethasone (200 μg twice daily) starting at the Prestudy Visit and continuing through the single-blind run-in period. Patients who experienced worsening asthma requiring more than albuterol therapy (inhaled or nebulized) did not qualify for randomization.
Patients were recruited at 22 sites in the United States (US) and 48 sites in 16 other countries in North America, Europe, Africa, Australia, and Southeast Asia.
Publication incorrectly listed 18 participating countries. Results posting is correct with 17 countries.
Prime therapy period: March 1995 to April 1996.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| FG001 | Montelukast | MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| FG002 | Beclomethasone | MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
| FG003 | Montelukast+ Beclomethasone | MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| 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 Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma | Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups | Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Change | Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups |
|
Over 16 weeks of treatment and for 14 days post-treatment
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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 (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture, Ankle | Injury, poisoning and procedural complications | Crisp Dictionary | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia/Fatigue | General disorders | Crisp Dictionary | Non-systematic Assessment |
Efficacy over 16 weeks of treatment for Beclo and MK+Beclo groups, and last 10 weeks for Placebo and MK groups to minimize confounding effect of beclo in 1st 4 weeks of treatment and to allow beclo washout.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| 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 |
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| beclomethasone | Drug | 200 ug inhaled, taken twice daily for 16 weeks |
|
| Placebo inhaler | Drug | placebo inhaler taken twice daily for 16 weeks |
|
| placebo tablet | Drug | placebo tablet taken once daily at bedtime for 16 weeks |
|
| Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma | Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
| Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only | Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | Montelukast | MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| BG002 | Beclomethasone | MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
| BG003 | Montelukast+ Beclomethasone | MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity | Number | participants |
|
| Daytime symptom score | Daytime symptom score: The patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis. | Mean | Standard Deviation | Units on a Scale |
|
| Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | Liters |
|
| Morning peak flow rate (PEFR) | Mean | Standard Deviation | Liters/minute |
|
| Nocturnal asthma score | Nocturnal asthma score: The patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. | Mean | Standard Deviation | Units on a Scale |
|
| Total daily Beta-agonist use | Number of inhalations (Puffs) of beta-agonist medication | Mean | Standard Deviation | Puffs |
|
Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
| OG001 | Montelukast | MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. |
| OG002 | Beclomethasone | MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
| OG003 | Montelukast+ Beclomethasone | MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. |
|
|
| Primary | Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma | The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits. | Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
|
|
|
| Secondary | Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use | Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits. | Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
|
|
|
| Secondary | Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma | Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits. | Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters/minute | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
|
|
|
| Secondary | Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only | Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits. | Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups |
|
|
|
| 1 |
| 48 |
| 36 |
| 48 |
| EG001 | Montelukast | MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed. | 4 | 201 | 150 | 201 |
| EG002 | Beclomethasone | MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. | 6 | 200 | 139 | 200 |
| EG003 | Montelukast+ Beclomethasone | MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed. | 1 | 193 | 123 | 193 |
| Pain, Back | Musculoskeletal and connective tissue disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Neurological Disorder | Nervous system disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Surgery, Nasopharyngeal | Surgical and medical procedures | Crisp Dictionary | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Crisp Dictionary | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | Crisp Dictionary | Non-systematic Assessment |
|
| Pain, Abdominal | General disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Pain, Back | Musculoskeletal and connective tissue disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Crisp Dictionary | Non-systematic Assessment |
|
| Infection, Respiratory, Upper | Infections and infestations | Crisp Dictionary | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Crisp Dictionary | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Crisp Dictionary | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Crisp Dictionary | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Crisp Dictionary | 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 |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |