Onset and Duration of Mometasone by Oscillometry and Spirometry

August 30, 2013 updated by: Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.

Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • California Allergy and Asthma Medical Group, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • by Nspire
Device: Oscillometry
Other Names:
  • by Jaeger, MS IOS Digital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOS
Time Frame: 4 weeks
Measurement of pulmonary function.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Allergy and Asthma Medical Group, Inc.

Investigators

  • Principal Investigator: Sheldon L Spector, MD, California Allergy and Asthma Medical Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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