Asthma, COPD
Conditions
Brief summary
This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.
Interventions
DRUGSCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.
Sponsors
Novartis
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis and Criteria for Inclusion: * A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months. * A participant must have been able to demonstrate correct use of an MDI without a counter at the Screening Visit. * A participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week Screening Period.
Exclusion criteria
* Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study. * Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Discrepancy Rate | 4-week Treatment Period | Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population). |
| Overall Quartile Discrepancy Rate | 4-week Treatment Period | Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals \[ie, quartiles\] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population. |
| Overall Discrepancy Size | 4-week Treatment Period | Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population. |
| End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) | 4-week Treatment Period | The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period. | 272 |
| Total | 272 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative | 1 |
| Overall Study | Adverse Event | 2 |
| Overall Study | Did not meet protocol eligibility | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Treatment Failure | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | MF/F MDI 100/10 mcg BID (With Dose Counter) |
|---|---|
| Age, Continuous Age 12 to <18 years of age | 14.69 years STANDARD_DEVIATION 1.64 |
| Age, Continuous Age 18 to <65 years of age | 44.22 years STANDARD_DEVIATION 12.12 |
| Age, Continuous Age ≥ 65 years of age | 70.43 years STANDARD_DEVIATION 4.77 |
| Number of Participants with Asthma and Chronic Obstructive Pulmonary Disease (COPD) Asthma | 222 Participants |
| Number of Participants with Asthma and Chronic Obstructive Pulmonary Disease (COPD) Chronic Obstructive Pulmonary Disease (COPD) | 50 Participants |
| Sex: Female, Male Female | 178 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 272 |
| serious Total, serious adverse events | 1 / 272 |
Outcome results
Primary
End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period.
Time frame: 4-week Treatment Period
Population: Completer Population, excluding 2 participants who used more than the labeled number of actuations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) | 175 Number of inhalers |
Primary
Overall Discrepancy Rate
Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population).
Time frame: 4-week Treatment Period
Population: Completer population, defined as participants who recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | Overall Discrepancy Rate | 0.13 Overall discrepancies per 100 actuations |
Primary
Overall Discrepancy Size
Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population.
Time frame: 4-week Treatment Period
Population: Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | Overall Discrepancy Size | 0.14 Discrepancy Size Per 100 actuations |
Primary
Overall Quartile Discrepancy Rate
Quartile discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded counter readout at each of the 4 weekly visit intervals \[ie, quartiles\] to evaluate whether there was any difference in agreement over the life of the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population.
Time frame: 4-week Treatment Period
Population: Completer Population, defined as participants who had recorded use of at least 90% of the labeled actuations during the 4-week Treatment Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | Overall Quartile Discrepancy Rate | 0.13 discrepancies per 100 actuations |