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Onset and Duration of Mometasone by Oscillometry and Spirometry

This study has been completed.
Information provided by (Responsible Party):
Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc. Identifier:
First received: June 29, 2012
Last updated: August 30, 2013
Last verified: August 2013
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.

Condition Intervention Phase
Drug: Mometasone furoate 220
Device: KoKo Spirometry
Drug: Mometasone furoate 440
Device: Oscillometry
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry

Resource links provided by NLM:

Further study details as provided by California Allergy and Asthma Medical Group, Inc.:

Primary Outcome Measures:
  • IOS [ Time Frame: 4 weeks ]
    Measurement of pulmonary function.

Enrollment: 21
Study Start Date: June 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Mometasone furoate 220 vs. Mometasone furoate 440 Drug: Mometasone furoate 220
dry powder inhaler QD for 28-43 days
Drug: Mometasone furoate 440
dry powder inhaler QD for 28-43 days
Active Comparator: Mometasone 220 mcg vs. 440 mcg
Inhaled steroid
Device: KoKo Spirometry
Other Name: by Nspire
Device: Oscillometry
Other Name: by Jaeger, MS IOS Digital


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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.
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Please refer to this study by its identifier: NCT01635088

United States, California
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, United States, 90025
Sponsors and Collaborators
California Allergy and Asthma Medical Group, Inc.
Principal Investigator: Sheldon L Spector, MD California Allergy and Asthma Medical Group, Inc.
  More Information

Responsible Party: Sheldon Spector, MD, President, California Allergy and Asthma Medical Group, Inc. Identifier: NCT01635088     History of Changes
Other Study ID Numbers: P05285
Study First Received: June 29, 2012
Last Updated: August 30, 2013

Keywords provided by California Allergy and Asthma Medical Group, Inc.:
FEV1 and IOS change after mometasone for asthma

Additional relevant MeSH terms:
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on April 28, 2017