Onset and Duration of Mometasone by Oscillometry and Spirometry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sheldon Spector, MD, California Allergy and Asthma Medical Group, Inc.
ClinicalTrials.gov Identifier:
NCT01635088
First received: June 29, 2012
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635088

Locations
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.
Investigators
Principal Investigator: Sheldon L Spector, MD California Allergy and Asthma Medical Group, Inc.
  More Information

No publications provided

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
Study First Received: June 29, 2012
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 27, 2014