NCT01635088CompletedPhase 4
Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry
California Allergy and Asthma Medical Group, Inc.1 site in 1 country21 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- IOS
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Mometasone furoate 220 vs. Mometasone furoate 440
Other
Intervention: Mometasone furoate 220 (Drug)
Mometasone furoate 220 vs. Mometasone furoate 440
Other
Intervention: Mometasone furoate 440 (Drug)
Mometasone 220 mcg vs. 440 mcg
Active Comparator
Inhaled steroid
Intervention: KoKo Spirometry (Device)
Mometasone 220 mcg vs. 440 mcg
Active Comparator
Inhaled steroid
Intervention: Oscillometry (Device)
Outcomes
Primary Outcomes
IOS
Time Frame: 4 weeks
Measurement of pulmonary function.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sheldon Spector, MD
President
California Allergy and Asthma Medical Group, Inc.
Study Sites (1)
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