Onset and Duration of Mometasone by Oscillometry and Spirometry

NCT01635088 | Completed Phase 4

• 1 other identifier: P05285
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; FEV1 and IOS change after mometasone for asthma

Outcome Measures

Primary Outcomes (1)

• IOS

  Measurement of pulmonary function.

  4 weeks

Study Arms (2)

Mometasone furoate 220 vs. Mometasone furoate 440

OTHER

Drug: Mometasone furoate 220; Drug: Mometasone furoate 440

Mometasone 220 mcg vs. 440 mcg

ACTIVE COMPARATOR

Inhaled steroid

Device: KoKo Spirometry; Device: Oscillometry

Interventions

Mometasone furoate 220 DRUG

dry powder inhaler QD for 28-43 days

Mometasone furoate 220 vs. Mometasone furoate 440

KoKo Spirometry DEVICE

Also known as: by Nspire

Mometasone 220 mcg vs. 440 mcg

Mometasone furoate 440 DRUG

dry powder inhaler QD for 28-43 days

Mometasone furoate 220 vs. Mometasone furoate 440

Oscillometry DEVICE

Also known as: by Jaeger, MS IOS Digital

Mometasone 220 mcg vs. 440 mcg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• California Allergy and Asthma Medical Group, Inc.: lead

Study Sites (1)

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Oscillometry

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sheldon L Spector, MD

  California Allergy and Asthma Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

US (1)