Clinical trial NCT01635088: Onset and Duration of Mometasone by Oscillometry and Spirometry
Official title: Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
FEV1 and IOS change after mometasone for asthma
Lead sponsor: California Allergy and Asthma Medical Group, Inc.
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: IOS
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group, Inc.
state: California
Study officials:
affiliation: California Allergy and Asthma Medical Group, Inc.
name: Sheldon L Spector, MD
role: PRINCIPAL_INVESTIGATOR
References: