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Onset and Duration of Mometasone by Oscillometry and Spirometry

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ClinicalTrials.gov Identifier: NCT01635088
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Mometasone furoate 220 Device: KoKo Spirometry Drug: Mometasone furoate 440 Device: Oscillometry Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry
Study Start Date : June 2011
Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Sheldon Spector, MD, President, California Allergy and Asthma Medical Group, Inc.
ClinicalTrials.gov Identifier: NCT01635088     History of Changes
Other Study ID Numbers: P05285
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

Keywords provided by Sheldon Spector, MD, 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