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Onset and Duration of Mometasone by Oscillometry and Spirometry

NCT ID: NCT01635088

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma FEV1 and IOS change after mometasone for asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mometasone furoate 220 vs. Mometasone furoate 440

Group Type OTHER

Mometasone furoate 220

Intervention Type DRUG

dry powder inhaler QD for 28-43 days

Mometasone furoate 440

Intervention Type DRUG

dry powder inhaler QD for 28-43 days

Mometasone 220 mcg vs. 440 mcg

Inhaled steroid

Group Type ACTIVE_COMPARATOR

KoKo Spirometry

Intervention Type DEVICE

Oscillometry

Intervention Type DEVICE

Interventions

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Mometasone furoate 220

dry powder inhaler QD for 28-43 days

Intervention Type DRUG

KoKo Spirometry

Intervention Type DEVICE

Mometasone furoate 440

dry powder inhaler QD for 28-43 days

Intervention Type DRUG

Oscillometry

Intervention Type DEVICE

Other Intervention Names

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by Nspire by Jaeger, MS IOS Digital

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Allergy and Asthma Medical Group, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Sheldon Spector, MD

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheldon L Spector, MD

Role: PRINCIPAL_INVESTIGATOR

California Allergy and Asthma Medical Group, Inc.

Locations

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California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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P05285

Identifier Type: -

Identifier Source: org_study_id