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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00835094
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Device: Mometasone furoate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma
Actual Study Start Date : October 1, 2002
Actual Primary Completion Date : July 1, 2003
Actual Study Completion Date : July 1, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Morning Device: Mometasone furoate
MF-DPI 400 mcg once daily in the morning for 12 weeks
Other Names:
  • Asmanex
  • SCH 32088

Experimental: Evening Device: Mometasone furoate
MF-DPI 400 mcg once daily in the evening for 12 weeks
Other Names:
  • Asmanex
  • SCH 32088

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]
  2. To compare the incidence of adverse events of MF-DPI 400 mcg once daily administered in the morning compared to the evening. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To assess morning vs. evening compliance with therapy. [ Time Frame: 12 weeks ]
  2. To assess subject satisfaction with the Twisthaler^TM device. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00835094     History of Changes
Other Study ID Numbers: P02177
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents