Back to resultsStudy of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
MF/F 200/10 mcg MDI BID
MF/F 400/10 mcg MDI BID
Arm Description
Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01566149
Brief Title
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
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])
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MF/F 200/10 mcg MDI BID
Arm Type
Active Comparator
Arm Description
Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
Arm Title
MF/F 400/10 mcg MDI BID
Arm Type
Active Comparator
Arm Description
Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Other Intervention Name(s)
Zenhale®, SCH 418131, MK-0887A
Intervention Description
Two oral inhalations per dose
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Other Intervention Name(s)
Zenhale®, SCH 418131, MK-0887A
Intervention Description
Two oral inhalations per dose
Primary Outcome Measure Information:
Title
Number of Participants With At Least One Adverse Event (AE)
Description
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.
Time Frame
Up to Week 14
Title
Number of Participants With At Least One Drug-Related AE
Description
A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Time Frame
Up to Week 14
Title
Number of Participants With At Least One Serious AE
Description
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.
Time Frame
Up to Week 14
Title
Number of Participants Who Discontinued From the Study Due to an AE
Description
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.
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Description
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%.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
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