Asthma
Conditions
Brief summary
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.
Interventions
DRUGMometasone
DRUGAdvair
Sponsors
Schering-Plough
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* subjects 18 to 65 years of age * a \>2 year history of asthma * FEV1 \> 80% for subjects currently using Advair®.
Exclusion criteria
* severe asthma * current smokers * pregnant or breast-feeding women * other chronic significant illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy as Assessed my Pulmonary Function Tests | change from baseline to study completion |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Mometasone
or
Advair | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 10 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized >=18, <=16 years | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Efficacy as Assessed my Pulmonary Function Tests
Time frame: change from baseline to study completion
Population: 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.