Onset and Duration of Mometasone by Oscillometry and Spirometry

California Allergy and Asthma Medical Group, Inc.

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Device: Oscillometry

Drug: Mometasone furoate 440

Drug: Mometasone furoate 220

Device: KoKo Spirometry

Study type

Interventional

Funder types

Other

Identifiers

NCT01635088

P05285

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.