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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
ClinicalTrials.gov Identifier:
NCT01566149
First received: March 27, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants with At Least One Adverse Event (AE) [ Time Frame: From Screening (Day -7) to 14 days after last dose of study drug (up to Day 42) ] [ Designated as safety issue: Yes ]
  • Number of Participants with At Least One Drug-Related AE [ Time Frame: From Screening (Day -7) to 14 days after last dose of study drug (up to Day 42) ] [ Designated as safety issue: Yes ]
  • Number of Participants with At Least One Serious AE [ Time Frame: From Screening (Day -7) to 14 days after last dose of study drug (up to Day 42) ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinue from the Study Due to an AE [ Time Frame: From Screening (Day -7) to 14 days after last dose of study drug (up to Day 42) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: Baseline (Week 0) and Week 12 ] [ Designated as safety issue: No ]

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 BID Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
MF/F 100/5 mcg MDI, 2 inhalations twice each day (BID)
Other Names:
  • Zenhale®
  • SCH 418131
Active Comparator: MF/F 400/10 mcg BID Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
MF/F 200/5 mcg MDI, 2 inhalations BID
Other Names:
  • Zenhale®
  • SCH 418131

  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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01566149     History of Changes
Other Study ID Numbers: P08212
Study First Received: March 27, 2012
Last Updated: October 16, 2012
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
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013