Full Text View
Tabular View
No Study Results Posted
Related Studies
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)(COMPLETED)
This study has been completed.
First Received: February 28, 2007   Last Updated: August 26, 2009   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00442117
  Purpose

This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.


Condition Intervention Phase
Asthma
Drug: mometasone furoate dry powder inhaler
Drug: Budesonide DPI
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The primary endpoint for the study is the percent change from baseline in FEV1. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in FVC, FEF(25%-75%), AM PEFR, nocturnal and daytime asthma symptoms based on a 4-point scale, assessment of response to therapy based on a 5-point scale, and the number of puffs of rescue medication. [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MF-DPI: Experimental
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day)
Drug: mometasone furoate dry powder inhaler
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
BUD-DPI: Active Comparator
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)
Drug: Budesonide DPI
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.

  Eligibility

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

Inclusion Criteria:

  • Subjects must be 12 years of age or older of either gender, who (and their parent/guardian if the subject is under the age of 20) must demonstrate their willingness to sign and write informed consent.
  • Subjects must have had a history of asthma for at least 6 months.
  • The subject must be diagnosed mild persistent or moderate persistent asthma and his/her FEV1 must be >= 60% of predicted normal at both the Screening and Baseline visits, when short-acting inhaled beta agonists have been withheld for at least six hours and long-acting inhaled beta agonists have been withheld for at least 12 hours.
  • Subjects must demonstrate an increase in absolute FEV1 of >= 12%, with an absolute volume increase of at least 200 mL, after reversibility testing at the Screening visit, or historically within the past 12 months; Subjects without documented absolute FEV1 of >= 12% in reversibility test within the past 12 months need to demonstrate a positive result in Methacholine challenge test.
  • If Subjects with ICS treatment have been using ICS on a daily basis for at least 4 weeks prior to Screening. For the two weeks prior to Screening, subjects must have been on a stable regimen of ICS. Each ICS dose is shown in following:

    • Flunisoloide between 1000 to 2000 mcg/day
    • Budesonide between 400 to 800 mcg/day
    • Triamcinolone acetonide between 600 to 1600 mcg/day
    • Beclomethasone Dipropionate between 252 to 840 mcg/day
    • Fluticasone propionate between 200 to 500 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 less than 1 year postmenopausal) must be using or agree to use an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation) if they become sexually active.
  • Subjects must understand and be able to adhere to visit schedules and enter information in a daily diary.

Exclusion Criteria:

  • Female subjects who are pregnant, breast-feeding, or are pre-menarcheal.
  • Subjects who are heavy smokers (more than 10 pack years) or who smoked within previous 6 months.
  • Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 14 days during the 3 months immediately prior to the Screening visit, and/or subjects who have required a course of systemic corticosteroids within the previous month.
  • Subjects who used Leukotriene modifiers within 2 weeks of screening.
  • Subjects who took immunosuppressive agents within the previous 3 months.
  • Subjects who use daily nebulized ß2-adrenergic agonists.
  • 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 have needed emergency service for asthma 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 evidence of clinically significant oropharyngeal candidiasis at Screening or Baseline.
  • Subjects with any clinically significant disorder of the cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or immunologic system, or respiratory disease other than asthma (e.g. COPD), or any other disorder which may interfere with the study evaluations or affect subject safety.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Bryan Wahking, MD - Medical Director, Taiwan Country Operations )
Study ID Numbers: P04880, SCH 900525
Study First Received: February 28, 2007
Last Updated: August 26, 2009
ClinicalTrials.gov Identifier: NCT00442117     History of Changes
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Mometasone furoate
Physiological Effects of Drugs
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010