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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_507 | Other Identifier | Merck |
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This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Placebo |
|
| Montelukast | Experimental | Montelukast |
|
| Nedocromil | Experimental | Nedocromil |
|
| Mometasone | Experimental | Mometasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nedocromil | Drug | Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Maximal percent drop in FEV1 at 20 minutes post allergen challenge | Pre-allergen challenge and 20 minutes after allergen challenge |
| Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes | Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge | Pre-allergen challenge and 5 minutes post allergen challenge |
| Change in Plasma 9P at 20 Minutes | Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge | Pre-allergen challenge and 20 minutes post allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Allergen-induced Changes in Urinary 9P | Fold change over baseline in Urinary 9P at 2 hours post allergen challenge | Baseline and 2 hours post allergen challenge |
| Allergen-induced Changes in Urinary Leukotriene (LT) E4 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Montelukast-Nedocromil-Mometasone | Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods. |
| FG001 | Placebo-Nedocromil-Montelukast-Mometasone | Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Placebo Run-in |
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| Period 2: 20-day Washout |
| |||||||||||||
| Period 3: Nedocromil-Montelukast X-over |
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| Period 4: 20-day Washout |
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| Period 5: Nedocromil-Montelukast X-over |
| |||||||||||||
| Period 6: 20-day Washout |
| |||||||||||||
| Period 7: Mometasone |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods. |
| 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 in Forced Expiratory Volume in 1 Second (FEV1) | Maximal percent drop in FEV1 at 20 minutes post allergen challenge | Posted | Least Squares Mean | Standard Deviation | Percentage drop in FEV1 | Pre-allergen challenge and 20 minutes after allergen challenge |
|
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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 | Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA (14.0) |
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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 |
|---|---|
| D017835 | Nedocromil |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Comparator: Montelukast |
| Drug |
Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge |
|
|
| Comparator: Mometasone | Drug | Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge |
|
| Placebo | Drug | Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet |
|
Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge
| Baseline and 2 hours post allergen challenge |
| Allergen-induced Concentrations of Sputum LTC4 | Concentrations of LTC4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge |
| Allergen-induced Concentrations of Sputum LTD4 | Concentrations of LTD4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge |
| Allergen-induced Concentrations of Sputum LTE4 | Concentrations of LTE4 in sputum at 2 hours post-allergen challenge | 2 hours post allergen challenge |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge |
| OG003 | Mometasone | Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge |
|
|
|
| Primary | Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes | Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge | Posted | Geometric Mean | Standard Deviation | Fold change over baseline | Pre-allergen challenge and 5 minutes post allergen challenge |
|
|
|
|
| Primary | Change in Plasma 9P at 20 Minutes | Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge | Posted | Geometric Mean | Standard Deviation | Fold change over baseline | Pre-allergen challenge and 20 minutes post allergen challenge |
|
|
|
|
| Secondary | Allergen-induced Changes in Urinary 9P | Fold change over baseline in Urinary 9P at 2 hours post allergen challenge | Only participants with baseline values were analyzed | Posted | Geometric Mean | Standard Deviation | Fold change over baseline | Baseline and 2 hours post allergen challenge |
|
|
|
|
| Secondary | Allergen-induced Changes in Urinary Leukotriene (LT) E4 | Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge | Only participants with baseline values were analyzed | Posted | Geometric Mean | Standard Deviation | Fold change over baseline | Baseline and 2 hours post allergen challenge |
|
|
|
|
| Secondary | Allergen-induced Concentrations of Sputum LTC4 | Concentrations of LTC4 in sputum at 2 hours post-allergen challenge | Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ. | Posted | Geometric Mean | Standard Deviation | pg/mL | 2 hours post allergen challenge |
|
|
|
|
| Secondary | Allergen-induced Concentrations of Sputum LTD4 | Concentrations of LTD4 in sputum at 2 hours post-allergen challenge | Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ. | Posted | Geometric Mean | Standard Deviation | pg/mL | 2 hours post allergen challenge |
|
|
|
|
| Secondary | Allergen-induced Concentrations of Sputum LTE4 | Concentrations of LTE4 in sputum at 2 hours post-allergen challenge | Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ. | Posted | Geometric Mean | Standard Deviation | pg/mL | 2 hours post allergen challenge |
|
|
|
|
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Nedocromil | Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge | 0 | 16 | 4 | 16 |
| EG002 | Montelukast | Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge | 0 | 15 | 3 | 15 |
| EG003 | Mometasone | Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge | 0 | 15 | 0 | 15 |
| Influenza Like Illness | General disorders | MedDRA (14.0) |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.0) |
|
| Joint Sprain | Injury, poisoning and procedural complications | MedDRA (14.0) |
|
| Headache | Nervous system disorders | MedDRA (14.0) |
|
| Presyncope | Nervous system disorders | MedDRA (14.0) |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) |
|
For multicenter studies, subsequent to the multicenter publication, an investigator and colleagues may publish their data independently. Limitations of single site observations should always be described in such a manuscript. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| ANCOVA |
concentrations evaluated at log scale |
| 0.0100 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. Mean Ratio of fold over baseline |
| 1.41 |
| 2-Sided |
| 90 |
| 1.15 |
| 1.72 |
| No |
| Superiority or Other |
| ANCOVA | concentrations evaluated at log scale | 0.0860 | p-Value not adjusted for simultaneous multiple comparisons | Geom. Mean Ratio of fold over baseline | 1.30 | 2-Sided | 90 | 1.01 | 1.67 | No | Superiority or Other |
| ANCOVA |
concentrations evaluated at log scale |
| <0.0001 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. Mean Ratio of fold over baseline |
| 0.59 |
| 2-Sided |
| 90 |
| 0.49 |
| 0.70 |
| No |
| Superiority or Other |
| ANCOVA | concentrations evaluated at log scale | 0.2679 | p-Value not adjusted for simultaneous multiple comparisons | Geom. Mean Ratio of fold over baseline | 0.87 | 2-Sided | 90 | 0.69 | 1.08 | No | Superiority or Other |
| ANCOVA |
concentrations evaluated on log scale |
| 0.8468 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. Mean Ratio of fold over baseline |
| 0.94 |
| 2-Sided |
| 90 |
| 0.53 |
| 1.65 |
| No |
| Superiority or Other |
| ANCOVA | concentrations evaluated at log scale | 0.6140 | p-Value not adjusted for simultaneous multiple comparisons | Geom. Mean Ratio of fold over baseline | 0.91 | 2-Sided | 90 | 0.65 | 1.26 | No | Superiority or Other |
| ANCOVA |
concentrations evaluated at log scale |
| 0.0291 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. Mean Ratio of fold over baseline |
| 0.79 |
| 2-Sided |
| 90 |
| 0.67 |
| 0.94 |
| No |
| Superiority or Other |
| ANCOVA | concentrations evaluated at log scale | 0.3738 | p-Value not adjusted for simultaneous multiple comparisons | Geom. Mean Ratio of fold over baseline | 0.92 | 2-Sided | 90 | 0.77 | 1.08 | No | Superiority or Other |
concentrations evaluated at log scale |
| 0.9410 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. mean of fold change over Placebo |
| 1.01 |
| 2-Sided |
| 90 |
| 0.81 |
| 1.25 |
| No |
| Superiority or Other |
| ANOVA | concentrations evaluated at log scale | 0.1165 | p-Value not adjusted for simultaneous multiple comparisons | Geom. mean of fold change over Placebo | 0.89 | 2-Sided | 90 | 0.79 | 1.01 | No | Superiority or Other |
| ANOVA |
concentrations evaluated at log scale |
| 0.7512 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. mean of fold change over Placebo |
| 1.06 |
| 2-Sided |
| 90 |
| 0.77 |
| 1.45 |
| No |
| Superiority or Other |
| ANOVA | concentrations evaluated at log scale | 0.9723 | p-Value not adjusted for simultaneous multiple comparisons | Geom. mean of fold change over Placebo | 0.99 | 2-Sided | 90 | 0.72 | 1.37 | No | Superiority or Other |
| ANOVA |
concentrations evaluated at log scale |
| 0.0872 |
p-Value not adjusted for simultaneous multiple comparisons |
| Geom. mean of fold change over Placebo |
| 1.57 |
| 2-Sided |
| 90 |
| 1.02 |
| 2.42 |
| No |
| Superiority or Other |
| ANOVA | concentrations evaluated at log scale | 0.2499 | p-Value not adjusted for simultaneous multiple comparisons | Geom. mean of fold change over Placebo | 1.22 | 2-Sided | 90 | 0.91 | 1.62 | No | Superiority or Other |