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| ID | Type | Description | Link |
|---|---|---|---|
| 065 | |||
| 2008_509 |
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The primary goals of this study will be to implement innovative processing and detection assays to qualify induced sputum measurements of markers of allergen-induced airway inflammation. The results of this study are intended to form a platform to be used in the clinical development of novel asthma therapeutics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | study medication + Pbo |
|
| Arm 2 | Experimental | Pbo + study medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: fluticasone | Drug | Two puffs, of 250 µg each, will be administered to each patient to obtain a 500-µg dose at each prespecified time point. A total of five (5) doses (500 µg) each of inhaled fluticasone will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day. |
| Measure | Description | Time Frame |
|---|---|---|
| Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL) | Baseline and 24 hours post allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL) | Baseline and 24 hours post allergen challenge |
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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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Inclusion
Randomized sequence of treatments including 500 μg fluticasone or placebo in treatment periods 1 & 2. Treatment was twice a day (b.i.d.) for total of 5 doses over 3-day period.
First Patient Entered: 28-Jan-2008
Last Patient, Last Visit: 05-Mar-2009
1 site
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Fluticasone | Days 1-2 Placebo twice a Day (b.i.d.) + Day 3 Placebo single dose, Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose |
| FG001 | Fluticasone Then Placebo | Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose, Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All Randomized Patients |
| 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 | Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL) | All Patients as Treated | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Baseline and 24 hours post allergen challenge |
|
|
Adverse experiences were collected from the time the consent is signed through the 14 day follow up period after all treatment periods were completed
AE s were assessed by clinical evaluation including vital signs, physical examination, medical history, clinical laboratory safety assessment (hematology, chemistry, urinalysis), and ECG at timepoints specified in the study. Patients were queried at each visit for any adverse experiences since the previous visit.
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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 | Days 1-2 Placebo b.i.d. + Day 3 Placebo single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | 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 |
| 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 |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
|
| Placebo | Drug | Two puffs, of placebo, will be administered to each patient at each prespecified time point. A total of five (5) doses of placebo will be administered during the single blind run-in phase. and matching placebo will be administered in a 3-day period during Periods 1 and 2. Dosing will be twice a day for 3 days, ending after the morning dose on the third day. |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Hour 24 Fold Change From Period Baseline in Interleukin-13 (IL-13) Protein Concentration (pg/mL) | All Patients as Treated | Posted | Geometric Mean | 95% Confidence Interval | pg/mL | Baseline and 24 hours post allergen challenge |
|
|
|
|
| 0 |
| 13 |
| 5 |
| 13 |
| EG001 | Fluticasone | Days 1-2 500 µg Fluticasone b.i.d. + Day 3 500 µg Fluticasone single dose | 0 | 13 | 6 | 13 |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Muscle Contractions Involuntary | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | 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 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |