Skip to main content
OpenTrials
Completed

NCT Number: NCT01635088

Onset and Duration of Mometasone by Oscillometry and 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, 90025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone furoate 220

Drug

dry powder inhaler QD for 28-43 days

KoKo Spirometry

Device

Other names: by Nspire

Mometasone furoate 440

Drug

dry powder inhaler QD for 28-43 days

Oscillometry

Device

Other names: by Jaeger, MS IOS Digital

Primary outcomes

  1. IOS

    Time frame: 4 weeks

    Measurement of pulmonary function.

Sponsors and collaborators

Lead sponsor

California Allergy and Asthma Medical Group, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
First posted
Jul 6, 2012
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.