Onset and Duration of Mometasone by Oscillometry and Spirometry

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635088
• Other study ID #: P05285
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2012
• Last updated: August 30, 2013
• Start date: June 2011

Study information

• Verified date: August 2013
• Source: California Allergy and Asthma Medical Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Mometasone furoate 220
dry powder inhaler QD for 28-43 days

Device:
• KoKo Spirometry

Drug:
• Mometasone furoate 440
dry powder inhaler QD for 28-43 days

Device:
• Oscillometry

Locations

Country	Name	City	State
United States	California Allergy and Asthma Medical Group, Inc.	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
California Allergy and Asthma Medical Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOS	Measurement of pulmonary function.	4 weeks	No