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Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
This study has been completed.
First Received: January 17, 2007   Last Updated: January 29, 2009   History of Changes
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00424008
  Purpose

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Condition Intervention Phase
Asthma
Drug: Mometasone furoate/formoterol (MF/F) combination
Drug: Fluticasone propionate and salmeterol (F/SC) DPI
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The AUC(0-12 hr) of the change from Baseline to Week 12 in FEV1. [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset-of-action based on change from Baseline FEV1 at the 5 min PFT assessment on Day 1. [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Change from Baseline in Asthma Control Questionnaire total score over the 52-week Treatment Period. [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  • Time-to-first asthma exacerbation over the 52-week Treatment Period. [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
  • The proportion of symptom-free days and nights (combined) over the 52-week Treatment Period. [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 664
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MF/F MDI 200/10 mcg BID: Experimental
Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily.
Drug: Mometasone furoate/formoterol (MF/F) combination
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
F/SC DPI 250/50 mcg BID: Active Comparator
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
Drug: Fluticasone propionate and salmeterol (F/SC) DPI
Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must have a diagnosis of asthma for at least 12 months' duration.
  • A subject must have been using a medium daily dose of inhaled glucocorticosteroids (alone or in combination with LABA) for at least 12 weeks and must have been on a stable regimen for at least 2 weeks prior to Screening.
  • If there is no inherent harm in changing the subject's current asthma therapy, the subject must be willing to discontinue his/her prescribed ICS or ICS/LABA prior to initiating MF MDO run-in medication.
  • The diagnosis of asthma must be documented by either demonstrating an increase in absolute forced expiratory volume in 1 second (FEV1) of at least 12% and a volume increase of at least 200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol or of nebulized SABA OR PEF variability of more than 20% OR a diurnal variation PEF of more than 20% based on the difference between pre-bronchodilator (before taking albuterol/salbutamol) morning value and the post-bronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period.
  • A subject must have a history of >= 2 asthma-related unscheduled visits to a physician or to an emergency room within the past year AND >= 3 asthma-related unscheduled visits within the past 2 years.
  • Prior to randomization subjects must have used a total of 12 or more inhalations of SABA rescue medication during the last 10 days of run-in.
  • Clinical laboratory tests (complete blood counts [CBC], blood chemistries, including serum pregnancy for females of child-bearing potential, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the subject is instructed to start using open-label MF MDI run-in medication.
  • An electrocardiogram (ECG) performed at the Screening Visit, using a centralized trans-telephonic technology, must be clinically acceptable to the investigator.
  • A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator.
  • A non-pregnant female subject of childbearing potential must be using a medically acceptable, adequate form of birth control. A female subject of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.

Exclusion Criteria:

  • A subject who demonstrates a change in absolute FEV1 of > 20% at any time between the Screening and Baseline Visits on any 2 consecutive days between the Screening and Baseline visits.
  • A subject who requires the use of greater than 8 inhalations per day of SABA MDI or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days between the Screening and Baseline Visits.
  • A subject who experiences a decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days prior to randomization. The average AM and average PM PEF respective values from the preceding 7 days are added, divided by the number of non-missing values, and multiplied by 0.70 to determine the stability limit.
  • A subject who experiences a clinical asthma exacerbation: defined as a clinical deterioration of asthma as judged by the clinical investigator between the Screening and Baseline Visits, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04705, SCH 418131
Study First Received: January 17, 2007
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00424008     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Glucocorticosteroids
Dry Powder Inhaler
Bronchodilator
Metered-Dose Inhaler

Study placed in the following topic categories:
Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Bronchial Diseases
Mometasone furoate
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Formoterol
Dermatologic Agents
Salmeterol
Immune System Diseases
Adrenergic beta-Agonists
Mometasone furoate
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 02, 2009