A Randomized Trial Assessing Once Daily Administration of Mometasone Furoate DPI in Asthmatics (Study P02177)

A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma

This will be an open-label, randomized, parallel-group comparison of mometasone furoate dry powder inhaler (MF-DPI) 400 mcg once daily administered in the morning vs. the evening for 12 weeks in subjects with asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Device: Mometasone furoate; Device: Mometasone furoate

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects (and their parent/guardian if the subject is <18) must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subjects must be >=12 years of age (unless restricted to an older age by local ethical committees or national health authorities), of either gender and any race.
• Subjects must have had a history of asthma for >=6 months.

• If the subject is taking inhaled corticosteroids, the daily dose must be <= the upper limit defined below:

  • budesonide <=800 mcg/day
  • triamcinolone acetonide <=800 mcg/day
  • beclomethasone dipropionate <=1000 mcg/day
  • fluticasone propionate <=500 mcg/day
  • flunisolide <=1000 mcg/day
• Women of childbearing potential must have a negative urine (hCG) pregnancy test on the day of randomization (Baseline visit).
• Women of childbearing potential (includes women who are <1 year postmenopausal) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation).
• Subjects must agree to inform their usual treating physician (if other than the study investigator) of their participation in this study.

Exclusion Criteria:

• Female subjects who are pregnant, breast-feeding, or are premenarcheal.
• Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 6 months immediately prior to Visit 1, and/or subjects who have required a course of systemic corticosteroids within the previous month.
• Subjects who have had either an asthma exacerbation or a clinically relevant change in asthma medication within the last 4 weeks.
• Subjects who have been admitted to the hospital for asthma control within the previous 3 months or more than once within the previous 6 months.
• Subjects who have required ventilator support for respiratory failure secondary to their asthma within the last 5 years.
• Subjects who have used any investigational drug in the 30 days prior to Baseline, or subjects who have been treated with any investigational antibody for asthma in the 90 days prior to Baseline.
• Subjects who are allergic or have had an idiosyncratic reaction to corticosteroids.
• Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (eg, COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.
• Subjects with a history of drug abuse, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morning	Device: Mometasone furoate; MF-DPI 400 mcg once daily in the morning for 12 weeks; Other Names: SCH 32088; Asmanex; Device: Mometasone furoate; MF-DPI 400 mcg once daily in the evening for 12 weeks; Other Names: SCH 32088; Asmanex
Experimental: Evening	Device: Mometasone furoate; MF-DPI 400 mcg once daily in the morning for 12 weeks; Other Names: SCH 32088; Asmanex; Device: Mometasone furoate; MF-DPI 400 mcg once daily in the evening for 12 weeks; Other Names: SCH 32088; Asmanex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Between-treatment group comparisons (MF-DPI 400 mcg once daily in the morning compared to the evening) of daytime and nocturnal symptoms based on a 4 point scale.	12 weeks
To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess morning vs. evening compliance with therapy.	12 weeks
To assess subject satisfaction with the Twisthaler^TM device.	12 weeks

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2002
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P02177

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis