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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_108 |
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This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Arm 1: Montelukast |
|
| 2 | Active Comparator | Arm 2: Fluticasone |
|
| 3 | Placebo Comparator | Arm 3: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | montelukast 10 mg tablet once daily, 6 month treatment period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Asthma-control Days Over the 6-month Treatment Period | An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period | 4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score. |
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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 |
|---|---|---|---|
| 23380218 | Result | Price D, Popov TA, Bjermer L, Lu S, Petrovic R, Vandormael K, Mehta A, Strus JD, Polos PG, Philip G. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013 Mar;131(3):763-71. doi: 10.1016/j.jaci.2012.12.673. Epub 2013 Feb 4. |
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Of the 1640 participants enrolled in the study, 621 participants were excluded during screening and not randomized. The remaining 1019 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast | Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| FG001 | Fluticasone | Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months |
| FG002 | Placebo | Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast | Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| BG001 | Fluticasone | Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months |
| 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 | Percentage of Asthma-control Days Over the 6-month Treatment Period | An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity. | Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication. | Posted | Mean | Standard Deviation | Percentage of days | 6 months |
|
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The population for safety analyses was the All Patients as Treated (APaT) set.
The set included all randomized participants who took at least one dose of the
double-blind study medication. One participant in the placebo group was randomized but did not take treatment. Therefore, participant was not included in the safety analyses.
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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 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | 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 |
| 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 |
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period |
|
| Comparator: fluticasone | Drug | fluticasone propionate 250 mcg twice daily, 6 month treatment period |
|
| Comparator: Placebo | Drug | montelukast 10 mg Pbo tablet once daily, 6 month treatment period |
|
| Baseline and 6 months |
| Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period | PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR. | Baseline and 6 months |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Other |
|
| BG002 | Placebo | Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Montelukast |
Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
| OG001 | Fluticasone | Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months |
| OG002 | Placebo | Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months |
|
|
|
| Secondary | Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period | 4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score. | Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months |
|
|
|
|
| Secondary | Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period | PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR. | Efficacy analysis was based on the full analysis set (FAS) population which included all participants who received at least one dose of the randomized double-blind study medication and who had at least 7 days of on-treatment data for the specific endpoint. | Posted | Mean | Standard Deviation | Liters/minute | Baseline and 6 months |
|
|
|
|
| 9 |
| 347 |
| 65 |
| 347 |
| EG001 | Fluticasone | Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months | 10 | 336 | 57 | 336 |
| EG002 | Placebo | Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months | 11 | 335 | 72 | 335 |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA 12.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Endometritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Salpingo-oophoritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Facial palsy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
The SPONSOR must have the opportunity to review all proposed abstracts,
manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as
confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Average Change from Baseline During Period II |
|
| Least Squares Mean Difference |
| -0.20 |
| 95 |
| -0.30 |
| -0.10 |
Estimated value is difference in least squares mean (fluticasone - placebo) |
| Superiority or Other (legacy) |
| Least Squares Mean Difference | 0.05 | 95 | -0.05 | 0.15 | Estimated value is difference in least squares mean (montelukast - fluticasone) | Superiority or Other (legacy) |
|
| Least Squares Mean Difference |
| 11.21 |
| 95 |
| 4.85 |
| 17.58 |
Estimated value is difference in least squares mean (fluticasone - placebo) |
| Superiority or Other (legacy) |
| Least Squares Mean Difference | -6.13 | 95 | -12.46 | 0.20 | Estimated value is difference in least squares mean (montelukast - fluticasone) | Superiority or Other (legacy) |