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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-386 | |||
| 2007_654 |
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This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.
During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | mometasone |
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| 2 | Placebo Comparator | montelukast followed by placebo; or placebo followed by montelukast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: mometasone | Drug | mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daytime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Daily β-agonist Use | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks |
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 |
|---|---|---|---|
| 21545249 | Result | Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/02770903.2011.573042. Epub 2011 May 5. |
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278 participants were screened; 144 were excluded.
Randomized patients met the following criteria: FEV1 (Forced expiratory volume in one second) 50-80% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA documented on at least two of the following visits: Visits 1, 2, and 3.
Patients were recruited from 25 centers worldwide. Patient screening began 05-May-2008 and the first patient was randomized on 29-May-2008.
The last patient's last visit was completed on 16-Feb-2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast + Mometasone Then Placebo + Mometasone | Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| Comparator: montelukast | Drug | montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks) |
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| Comparator: placebo (unspecified) | Drug | Placebo (Placebo once-daily, for approximately 2 weeks) |
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| Baseline and 2 weeks |
| Change From Baseline in Nighttime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks |
| Percentage of Days With Asthma Control | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | 2 weeks |
| Percentage of Days With Asthma Exacerbations | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period. | 2 Weeks |
| Change From Baseline in Total Peripheral Blood Eosinophils | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period. | Baseline and 2 weeks |
| FG001 | Placebo + Mometasone Then Montelukast + Mometasone | Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation. |
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| NOT COMPLETED |
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| Washout Period of 1 Week |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast + Mometasone Then Placebo + Mometasone | Patients were randomized to receive montelukast 1 mg (milligram) and open-label mometasone 220 mcg (micrograms) once daily by inhalation in the first intervention; and placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation. |
| BG001 | Placebo + Mometasone Then Montelukast + Mometasone | Patients were randomized to receive placebo for montelukast and open-label mometasone 220 mcg once daily by inhalation in the first intervention; and montelukast 1 mg and open-label mometasone 220 mcg once daily by inhalation in the second intervention (after washout). During washout, patients received open-label inhaled mometasone 220 mcg and single-blind placebo for montelukast once daily by inhalation. |
| BG002 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Daytime Asthma Symptom Score (0 [best] to 6 [worst] Point Scale) | Mean | Standard Deviation | Units on a Scale |
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| FEV1 (Forced Expiratory Volume in One Second) | Mean | Standard Deviation | L (Liter) |
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| Nighttime Asthma Symptom Score (0 [best] to 3 [worst] Point Scale) | Mean | Standard Deviation | Units on a Scale |
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| Total Daily Beta-Agonist Use | Mean | Standard Deviation | Puffs |
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| Total Peripheral Blood Eosinophils | Mean | Standard Deviation | 10^3/microliters |
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| 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 in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | L (Liter) | Baseline and 2 weeks |
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| Secondary | Change From Baseline in Daytime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and 2 weeks |
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| Secondary | Change From Baseline in Nighttime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | The analysis was based on a subset of the FAS population which included all randomized patients with nighttime symptoms at baseline (score>0), who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a Scale | Baseline and 2 weeks |
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| Other Pre-specified | Change From Baseline in Total Daily β-agonist Use | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Puffs | Baseline and 2 weeks |
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| Other Pre-specified | Percentage of Days With Asthma Control | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 2 weeks |
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| Other Pre-specified | Percentage of Days With Asthma Exacerbations | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period. | The analysis was based on the Completers Set population which included all randomized patients who took a dose of blinded post randomization study drug (inhaled montelukast or matching placebo) in both treatment periods and had a measurement for analysis available in both treatment periods of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Days | 2 Weeks |
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| Other Pre-specified | Change From Baseline in Total Peripheral Blood Eosinophils | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period. | The analysis was based on the FAS population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design. | Posted | Least Squares Mean | 95% Confidence Interval | 10^3/microliter | Baseline and 2 weeks |
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| Post-Hoc | Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit. | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average. | The analysis was based on a subset of the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug, had a measurement for analysis available in at least one treatment period and met lung function eligibility criteria specifically at the randomization visit. | Posted | Least Squares Mean | 95% Confidence Interval | L (Liter) | Baseline and 2 Weeks |
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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 + Mometasone | Inhaled montelukast 1 mg (milligram) and open label mometasone 220 mcg (micrograms) once daily. | 1 | 130 | 24 | 130 | ||
| EG001 | Placebo + Mometasone | Inhaled placebo for montelukast and open label mometasone 220 mcg once daily. | 1 | 129 | 24 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Acarodermatitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Pulpitis dental | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral pharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Viral rhinitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| White blood cells urine positive | Investigations | MedDRA 11.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Allergic pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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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.
| 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 |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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