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Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (Study P04139AM1)(COMPLETED)
This study has been completed.
First Received: September 19, 2006   Last Updated: February 29, 2008   History of Changes
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00379288
  Purpose

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 Intervention 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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The number and percent of all randomized subjects reporting adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 24-hr plasma cortisol AUCs (based on data collected) & ECGs summarized using descriptive statistics. Number & percent randomized subjects w/newly developed cataracts (graded by LOCS III), & intraocular pressure >=22 mm Hg, summarized by treatment group. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: June 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MF/F 200/10 mcg BID: Experimental 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
MF/F 400/10 mcg BID: Experimental 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
F/SC 250/50 mcg BID: Active Comparator Drug: Fluticasone/Salmeterol 250/50 mcg BID
FS/c 250/50 twice daily for 1 year
F/SC 500/50 mcg BID: Active Comparator Drug: Fluticasone/Salmeterol 500/50 mcg BID
FS/C 500/50 twice daily for 1 year

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379288

Sponsors and Collaborators
Schering-Plough
Investigators
Study Director: Hendrik Nolte Director, Allergy/Respiratory Diseases/Clinical Immunology
  More Information

No publications provided

Responsible Party: Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology )
Study ID Numbers: P04139
Study First Received: September 19, 2006
Last Updated: February 29, 2008
ClinicalTrials.gov Identifier: NCT00379288     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Peru: National Institute of Health;   Mexico: Ministry of Health;   Chile: Instituto de Salud Publica de Chile;   Ecuador: Public Health Ministry;   Guatemala:Ministry of Public Health and Social Welfare

Study placed in the following topic categories:
Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Adrenergic Agents
Adrenergic beta-Agonists
Mometasone furoate
Albuterol
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Adrenergic Agonists
Vitamin C
Fluticasone
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Ascorbic Acid

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Salmeterol
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Mometasone furoate
Physiological Effects of Drugs
Albuterol
Anti-Asthmatic Agents
Reproductive Control Agents
Anti-Allergic Agents
Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on July 02, 2009