Asthma
Conditions
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.
Interventions
DRUGMometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI
Two oral inhalations per dose
DRUGMometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Two oral inhalations per dose
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With At Least One Adverse Event (AE) | Up to Week 14 | 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 | Up to Week 14 | 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 | Up to Week 14 | 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 | Up to Week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline and 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%. |
Participant flow
Recruitment details
Participants were recruited from one study site in Vietnam between March 2012 and September 2012.
Pre-assignment details
Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.
Participants by arm
| Arm | Count |
|---|---|
| MF/F 200/10 mcg MDI BID Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks | 24 |
| MF/F 400/10 mcg MDI BID Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks | 25 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Non-compliance with study medication | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | MF/F 200/10 mcg MDI BID | MF/F 400/10 mcg MDI BID | Total |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 14.48 | 41.2 years STANDARD_DEVIATION 14.91 | 38.3 years STANDARD_DEVIATION 14.84 |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 24 | 8 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
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.
Time frame: Up to Week 12
Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Number of Participants Who Discontinued From the Study Due to an AE | 0 participants |
| MF/F 400/10 mcg MDI BID | Number of Participants Who Discontinued From the Study Due to an AE | 1 participants |
Primary
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.
Time frame: Up to Week 14
Population: The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Number of Participants With At Least One Adverse Event (AE) | 5 participants |
| MF/F 400/10 mcg MDI BID | Number of Participants With At Least One Adverse Event (AE) | 8 participants |
Primary
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.
Time frame: Up to Week 14
Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Number of Participants With At Least One Drug-Related AE | 0 participants |
| MF/F 400/10 mcg MDI BID | Number of Participants With At Least One Drug-Related AE | 0 participants |
Primary
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.
Time frame: Up to Week 14
Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F 200/10 mcg MDI BID | Number of Participants With At Least One Serious AE | 0 participants |
| MF/F 400/10 mcg MDI BID | Number of Participants With At Least One Serious AE | 0 participants |
Secondary
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%.
Time frame: Baseline and Week 12
Population: The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MF/F 200/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline FEV1 | 2.397 liters | Standard Deviation 0.6824 |
| MF/F 200/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Week 12 FEV1 | 2.503 liters | Standard Deviation 0.7418 |
| MF/F 200/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Change from Baseline in FEV1 at Week 12 | 0.106 liters | Standard Deviation 0.2892 |
| MF/F 400/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Baseline FEV1 | 2.215 liters | Standard Deviation 0.6206 |
| MF/F 400/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Week 12 FEV1 | 2.270 liters | Standard Deviation 0.6041 |
| MF/F 400/10 mcg MDI BID | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 | Change from Baseline in FEV1 at Week 12 | 0.054 liters | Standard Deviation 0.2055 |