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Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)

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ClinicalTrials.gov Identifier: NCT00379288
Recruitment Status : Completed
First Posted : September 21, 2006
Results First Posted : August 12, 2010
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Description
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Brief Summary:

The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.


Condition or disease Intervention/treatment Phase
Asthma Drug: mometasone furoate combination MDI 200/10 mcg BID Drug: mometasone furoate combination MDI 400/10 mcg BID Drug: Fluticasone/Salmeterol 250/50 mcg BID Drug: Fluticasone/Salmeterol 500/50 mcg BID Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
Study Start Date : June 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: MF/F 200/10 mcg BID Drug: mometasone furoate combination MDI 200/10 mcg BID
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Other Name: SCH 418131
Experimental: MF/F 400/10 mcg BID Drug: mometasone furoate combination MDI 400/10 mcg BID
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
Other Name: SCH 418131
Active Comparator: F/SC 250/50 mcg BID Drug: Fluticasone/Salmeterol 250/50 mcg BID
F/SC 250/50 twice daily for 1 year
Other Name: Seretide
Active Comparator: F/SC 500/50 mcg BID Drug: Fluticasone/Salmeterol 500/50 mcg BID
F/SC 500/50 twice daily for 1 year
Other Name: Seretide


Outcome Measures
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Primary Outcome Measures :
  1. The Number of All Randomized Subjects Reporting Adverse Events (AEs). [ Time Frame: 1 year ]
    AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months.

  • Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist [LABA]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening.

    • Medium daily doses of ICS:

      • > 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC)
      • > 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA)
      • > 600 to 1000 mcg budesonide dry powder inhaler (DPI)
      • > 1000 to 2000 mcg flunisolide
      • > 250 to 500 mcg fluticasone
      • 400 mcg MF
      • > 1000 to 2000 mcg triamcinolone acetonide

    • High daily doses of ICS:

      • > 1000 mcg beclomethasone CFC
      • > 500 mcg beclomethasone HFA
      • > 1000 mcg budesonide DPI
      • > 2000 mcg flunisolide
      • > 500 mcg fluticasone
      • > 400 mcg MF
      • > 2000 mcg triamcinolone acetonide
  • If there is no inherent harm in changing the subject's current asthma therapy, the subject must discontinue prescribed ICS or ICS/LABA combination at Baseline.
  • Must show evidence of reversibility within the last 12 months or during the Screening Period. Historical reversibility defined as an increase in absolute forced expiratory volume in 1 second (FEV1) of >= 12% and >= 200 mL will qualify if performed within 12 months of Screening. If no historical reversibility, subject must demonstrate an absolute FEV1 of >= 12% and >= 200 mL within 10 to 15 minutes after four puffs of salbutamol at Visit 1 or anytime prior to Baseline.
  • At Screening and Baseline, FEV1 must be >= 50% predicted, when restricted medications are withheld for the appropriate intervals.
  • Complete blood count, blood chemistries, urinalysis, and electrocardiogram (ECG) conducted at Screening must be within normal limits or clinically acceptable to the investigator/sponsor. A chest x-ray performed at Screening or within 12 months prior must be clinically acceptable.

  • A female of childbearing potential must be using a medically acceptable, adequate form of birth control:

    • prescribed hormonal contraceptives;
    • medically prescribed intrauterine device (IUD);
    • medically prescribed transdermal contraceptive;
    • condom in combination with spermicide;
    • monogamous relationship with a male partner who has had a vasectomy.

Birth control must have started at least 3 months prior to Screening. Subject must agree to continue its use for the duration of the study. A subject of childbearing potential who is not currently sexually active must agree to use a medically acceptable method should she become sexually active during the study. Women who have been surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. A subject of childbearing potential must have a negative serum pregnancy test at Screening.

Key Exclusion Criteria:

  • A change (increase or decrease) in absolute FEV1 of > 20% at any time from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who requires the use of > 12 inhalations per day of short-acting beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [other than SABA]) at any time from the Screening Visit up to, and including, the Baseline Visit.
  • A subject who has ever required ventilator support for respiratory failure secondary to asthma.
  • A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history > 10 pack-years.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00379288    
Other Study ID Numbers: P04139
First Posted: September 21, 2006    Key Record Dates
Results First Posted: August 12, 2010
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Mometasone Furoate
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids