Not provided
Not provided
Not provided
Not provided
Not provided
by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?
The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone | Experimental |
| |
| Advair | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone | Drug |
| ||
| Advair |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Assessed my Pulmonary Function Tests | change from baseline to study completion |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter S Creticos, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
33 participants were consented for this study. However, there were 23 pre-randomization screening failures. Only 10 were enrolled. The number of participants assigned/randomized to each Arm/Group is unknown.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Mometasone or Advair |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of participants assigned/randomized to each Arm/Group is unknown
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Mometasone or Advair |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Efficacy as Assessed my Pulmonary Function Tests | There is no data available for this outcome measure. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB. | Posted | change from baseline to study completion |
|
|
Not provided
There is no data available for adverse events. The study was prematurely terminated and the PI is no longer with the institution. The information available was obtained from the IRB.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Mometasone or Advair Adverse event data and the number of participants assigned to each Arm/Group is unknown because the PI left the institution and this information is unavailable |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins University Clinical Trials Program | Johns Hopkins University School of Medicine | 410-550-6484 | registerclinicaltrials@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |