Onset and Duration of Mometasone by Oscillometry and Spirometry

Study Overview
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Brief Summary
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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.

Official Title
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Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry

Conditions
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Asthma

Intervention / Treatment
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* Drug: Mometasone furoate 220
* Device: KoKo Spirometry
* Drug: Mometasone furoate 440
* Device: Oscillometry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mometasone furoate 220 vs. Mometasone furoate 440<br> | Drug: Mometasone furoate 220<br>* dry powder inhaler QD for 28-43 days<br>Drug: Mometasone furoate 440<br>* dry powder inhaler QD for 28-43 days<br>|
| Active Comparator: Mometasone 220 mcg vs. 440 mcg<br>Inhaled steroid | Device: KoKo Spirometry<br> <br> * Other names: by Nspire;Device: Oscillometry<br> <br> * Other names: by Jaeger, MS IOS Digital;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOS | Measurement of pulmonary function. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FEV1 and IOS change after mometasone for asthma, Asthma