Asthma
Conditions
Keywords
Asthma, FEV1 and IOS change after mometasone for asthma
Brief summary
Inhaled corticosteroids (ICS) are appreciated for their long term anti-inflammatory effects in chronic asthma. However, they also have largely unappreciated early effects when initiated as a controller therapy in a steroid-naïve population. Impulse oscillometry might reveal such an early effect better than spirometry. The investigators sought to examine the onset of action and sustained effects over 4 weeks treatment of mometasone furoate as measured by Impulse Oscillometry System (IOS) versus spirometry.
Interventions
DRUGMometasone furoate 220
dry powder inhaler QD for 28-43 days
DEVICEKoKo Spirometry
DRUGMometasone furoate 440
dry powder inhaler QD for 28-43 days
DEVICEOscillometry
Sponsors
California Allergy and Asthma Medical Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-65 years inclusive. * Written informed consent (conducted according to the GCP and ICH guidelines) to participate in the study. Ability to comply with all study requirements. * Mild to moderate persistent asthma with symptoms at least 2 times per week, managed by as-needed SABA only. * A 35% or greater improvement in small airway dysfunction defined by IOS AX after inhaled SABA. * Allergic response to one or more common allergens at screening via skin test. * Male, or female of childbearing potential using a medically approved birth control method. * Evidence of SAD manifested by an index of peripheral airway reactance of \> 10.5 cm H2O/L (3 times the upper limit of adult normal). * Symptoms of airflow obstruction (i.e. dyspnea on exertion greater than peers at similar exercise levels, wheeze, or cough \> 3 weeks without respiratory infection, or nocturnal dyspnea, and use of SABA \> 2 times per week)
Exclusion criteria
* Subjects with severe persistent asthma and/or subjects taking inhaled or systemic corticosteroids or long acting beta agonists (LABA). * Subjects \< 18 years of age or \> 65 years. * Pregnant or lactating females. * History of diabetes. * Acute infections within 4 weeks prior to Screening. * Concurrent medical condition that might interfere with the interpretation of efficacy and safety data during the study. * Contraindications and warnings according to the specific label for Asmanex. * Chronic inhaled or systemic corticosteroid treatment (\> 7 consecutive days of treatment) within 30 days prior to Screening. * Investigational drug treatment within 30 days prior to Screening. Treatment with any drug with a known and frequent toxicity to a major organ system within the past 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOS | 4 weeks | Measurement of pulmonary function. |
Countries
United States
Outcome results
None listed