Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
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])
2 other identifiers
interventional
49
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Mar 2012
Shorter than P25 for phase_3 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
July 29, 2013
CompletedMay 24, 2024
February 1, 2022
6 months
March 27, 2012
May 28, 2013
May 9, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline and Week 12
Study Arms (2)
MF/F 200/10 mcg MDI BID
ACTIVE COMPARATORParticipants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks
MF/F 400/10 mcg MDI BID
ACTIVE COMPARATORParticipants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Interventions
Two oral inhalations per dose
Two oral inhalations per dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2012
First Posted
March 29, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
May 24, 2024
Results First Posted
July 29, 2013
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share