Trial Outcomes & Findings for A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1) (NCT NCT00604500)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

272 participants

Primary outcome timeframe

4-week Treatment Period

Results posted on

2024-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	272
Overall Study COMPLETED	261
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	2
Overall Study Protocol Violation	2
Overall Study Treatment Failure	1
Overall Study Withdrawal by Subject	4
Overall Study Administrative	1
Overall Study Did not meet protocol eligibility	1

Baseline Characteristics

A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n=272 Participants 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.
Age, Continuous Age 12 to <18 years of age	14.69 years STANDARD_DEVIATION 1.64 • n=5 Participants
Age, Continuous Age 18 to <65 years of age	44.22 years STANDARD_DEVIATION 12.12 • n=5 Participants
Age, Continuous Age ≥ 65 years of age	70.43 years STANDARD_DEVIATION 4.77 • n=5 Participants
Sex: Female, Male Female	178 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants
Number of Participants with Asthma and Chronic Obstructive Pulmonary Disease (COPD) Asthma	222 Participants n=5 Participants
Number of Participants with Asthma and Chronic Obstructive Pulmonary Disease (COPD) Chronic Obstructive Pulmonary Disease (COPD)	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n=233 Participants 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.
Overall Discrepancy Rate	0.13 Overall discrepancies per 100 actuations

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n=233 Participants 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.
Overall Quartile Discrepancy Rate	0.13 discrepancies per 100 actuations

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n=233 Participants 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.
Overall Discrepancy Size	0.14 Discrepancy Size Per 100 actuations

PRIMARY outcome

Timeframe: 4-week Treatment Period

Population: Completer Population, excluding 2 participants who used more than the labeled number of actuations.

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.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID (With Dose Counter) n=233 Participants 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.
End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)	175 Number of inhalers

Adverse Events

MF/F MDI 100/10 mcg BID

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MF/F MDI 100/10 mcg BID n=272 participants at risk Included all participants that received 100/10 mcg BID (with and without dose counter)
General disorders Oedema Peripheral	0.37% 1/272 • Number of events 1 • 6 weeks Participants received open-label MF/F 100/10 mcg BID during the 2-week Screening Period and the 4-week Treatment Period. All participants who received at least one dose of MF/F were included in the safety analysis.

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp and Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agrees not to publish/present any interim results without prior sponsor written consent. The investigator agrees to provide to the sponsor, 45 days prior to submission, review copies for publication that report any study results. The sponsor has the right to review and comment. If the parties disagree, investigator agrees to meet with the sponsor, prior to submission for publication, to discuss and resolve any such issues/disagreement.
Publication restrictions are in place

Restriction type: OTHER