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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00835094
First received: October 30, 2008
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Asthma
Device: Mometasone furoate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess morning vs. evening compliance with therapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To assess subject satisfaction with the Twisthaler^TM device. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: October 2002
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00835094     History of Changes
Other Study ID Numbers: P02177
Study First Received: October 30, 2008
Last Updated: April 24, 2014
Health Authority: Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 24, 2014