Onset and Duration of Mometasone by Oscillometry and Spirometry

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01635088

Run by

California Allergy and Asthma Medical Group, Inc.

People needed

21

Starts

2011-06-01

Last updated by the study team

2013-09-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• California Allergy and Asthma Medical Group, Inc. — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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