Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01566149
First received: March 27, 2012
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to assess the safety, tolerability & effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults & adolescents.


Condition Intervention Phase
Asthma
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With At Least One Adverse Event (AE) [ Time Frame: Up to Week 14 ] [ Designated as safety issue: Yes ]
    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

  • Number of Participants With At Least One Drug-Related AE [ Time Frame: Up to Week 14 ] [ Designated as safety issue: Yes ]
    A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.

  • Number of Participants With At Least One Serious AE [ Time Frame: Up to Week 14 ] [ Designated as safety issue: Yes ]

    A serious AE was defined as any untoward medical occurrence or effect that at

    any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.


  • Number of Participants Who Discontinued From the Study Due to an AE [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.


Secondary Outcome Measures:
  • Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.


Enrollment: 49
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MF/F 200/10 mcg MDI BID
Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Two oral inhalations per dose
Other Names:
  • Zenhale®
  • SCH 418131
  • MK-0887A
Active Comparator: MF/F 400/10 mcg MDI BID
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Two oral inhalations per dose
Other Names:
  • Zenhale®
  • SCH 418131
  • MK-0887A

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of asthma of at least 6 months duration
  • Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
  • Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
  • If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive

Exclusion Criteria:

  • Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
  • Any prior ventilator support for respiratory failure secondary to asthma,
  • Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
  • History of a medical condition that, in the investigator's opinion, may interfere with study participation,
  • History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
  • Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications
  • History of use of illicit drugs
  • Inability to correctly use an oral MDI
  • Pregnant, breastfeeding or plans to become pregnant during study
  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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01566149     History of Changes
Other Study ID Numbers: P08212, MK-0887A-206
Study First Received: March 27, 2012
Results First Received: May 28, 2013
Last Updated: July 22, 2014
Health Authority: Vietnam: Ministry of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Mometasone furoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 21, 2014