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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-388 | |||
| 2008_542 |
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This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | montelukast Placebo |
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| 2 | Experimental | montelukast |
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| 3 | Experimental | montelukast |
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| 4 | Experimental | montelukast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: montelukast | Drug | 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 Over 4 Hours | FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. | 0 (=baseline) to 4 hours after treatment with montelukast |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration | FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast | Average change from baseline in FEV1 at 8 hours after single dose montelukast administration. | 0 (baseline) and 8 hours after treatment with montelukast |
| Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast |
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 |
|---|---|---|---|
| 20936994 | Derived | Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3. |
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117 participants were screened; 49 were excluded. Randomized patients met the following criteria during the prestudy period: FEV1 (Forced expiratory volume in one second) 50-85% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA at Visits 1 and 2.
Patients were recruited from 6 centers in the United States between July and December 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG001 | 25 mcg Montelukast | Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG002 | 100 mcg Montelukast | Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG003 | 250 mcg Montelukast | Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG004 | 500 mcg Montelukast | Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG005 | 1000 mcg Montelukast | Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| FG006 | Total | Consistent with the "incomplete-block" design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Visit 3 to Visit 4) |
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| First Washout Period of 4-7 Days |
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| Second Intervention (Visit 5 to Visit 6) |
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| Second Washout Period of 4-7 Days |
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| Third Intervention (Visit 7 to Visit 8) |
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| Third Washout Period of 4-7 Days |
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| Fourth Intervention(Visit 9 to Visit 10) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Combined participants from all arms. |
| 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 | Change From Baseline in FEV1 Over 4 Hours | FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. | Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits 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) | 0 (=baseline) to 4 hours after treatment with montelukast |
|
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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 | Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Non-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 |
|---|---|
| C093875 | montelukast |
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|
|
| Comparator: placebo | Drug | 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo. |
|
| 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast |
Average change from baseline in FEV1 at 24 hours after single dose montelukast administration. |
| 0 (baseline) and 24 hours after treatment with montelukast |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| FEV1 (Forced Expiratory Volume in One Second) | Mean | Standard Deviation | L (Liter) |
|
| OG001 | 25 mcg Montelukast | Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| OG002 | 100 mcg Montelukast | Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| OG003 | 250 mcg Montelukast | Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| OG004 | 500 mcg Montelukast | Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
| OG005 | 1000 mcg Montelukast | Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). |
|
|
|
| Secondary | Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration | FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement. | Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits 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 | 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast |
|
|
|
|
| Other Pre-specified | Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast | Average change from baseline in FEV1 at 8 hours after single dose montelukast administration. | Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits 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 | 0 (baseline) and 8 hours after treatment with montelukast |
|
|
|
|
| Other Pre-specified | Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast | Average change from baseline in FEV1 at 24 hours after single dose montelukast administration. | Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits 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 | 0 (baseline) and 24 hours after treatment with montelukast |
|
|
|
|
| 0 |
| 67 |
| 4 |
| 67 |
| EG001 | 25 mcg Montelukast | Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). | 0 | 41 | 1 | 41 |
| EG002 | 100 mcg Montelukast | Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). | 0 | 30 | 0 | 30 |
| EG003 | 250 mcg Montelukast | Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). | 0 | 66 | 3 | 66 |
| EG004 | 500 mcg Montelukast | Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). | 0 | 25 | 3 | 25 |
| EG005 | 1000 mcg Montelukast | Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment). | 0 | 36 | 0 | 36 |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | 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.
| Difference in Least-Squares Means |
| 0.07 |
| 95 |
| -0.00 |
| 0.15 |
Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. |
| Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.05 | 95 | -0.01 | 0.11 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.06 | 95 | -0.03 | 0.14 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.08 | 95 | 0.01 | 0.15 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |
| Difference in Least-Squares Means |
| 0.09 |
| 95 |
| 0.01 |
| 0.17 |
Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. |
| Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.05 | 95 | -0.01 | 0.10 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.07 | 95 | -0.02 | 0.15 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |
| Difference in Least-Squares Means | 0.08 | 95 | 0.01 | 0.15 | Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate. | Superiority or Other (legacy) |