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

Study Overview
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Brief Summary
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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.

Official Title
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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])

Conditions
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Asthma

Intervention / Treatment
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* Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
* Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MF/F 200/10 mcg MDI BID<br>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<br>* Two oral inhalations per dose<br>* Other names: MK-0887A;|
| Active Comparator: MF/F 400/10 mcg MDI BID<br>Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks | Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI<br>* Two oral inhalations per dose<br>* Other names: MK-0887A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With At Least One Adverse Event (AE) | 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. | Up to Week 14 | 
| Number of Participants With At Least One Drug-Related AE | A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator. | Up to Week 14 | 
| Number of Participants With At Least One Serious AE | 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. | Up to Week 14 | 
| Number of Participants Who Discontinued From the Study Due to an AE | 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. | Up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | 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%. | Baseline and Week 12 |