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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00379288
First received: September 19, 2006
Last updated: February 5, 2014
Last verified: February 2014
  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 3

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 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 Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The Number of All Randomized Subjects Reporting Adverse Events (AEs). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 404
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
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

  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.

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
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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00379288     History of Changes
Other Study ID Numbers: P04139
Study First Received: September 19, 2006
Results First Received: July 15, 2010
Last Updated: February 5, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Peru: National Institute of Health
Mexico: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Ecuador: Public Health Ministry
Guatemala:Ministry of Public Health and Social Welfare

Additional relevant MeSH terms:
Fluticasone
Mometasone furoate
Salmeterol
Albuterol
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
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
Tocolytic Agents
Reproductive Control Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on September 15, 2014