Trial Outcomes & Findings for A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880) (NCT NCT00442117)

Results Overview

FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

180 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2024-05-20

Participant Flow

A total of 180 participants were enrolled and randomized. There were 8 participants who had taken at least one dose of study medication, but were not eligible for the study and therefore were withdrawn, resulting in the Intent-to-Treat (ITT) population of 172 participants.

Participant milestones

Participant milestones
Measure	MF-DPI Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Overall Study STARTED	85	87
Overall Study COMPLETED	47	49
Overall Study NOT COMPLETED	38	38

Reasons for withdrawal

Reasons for withdrawal
Measure	MF-DPI Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Overall Study Adverse Event	3	2
Overall Study Lack of Efficacy	2	6
Overall Study Lost to Follow-up	1	2
Overall Study Withdrawal by Subject	2	2
Overall Study Major Deviation	25	20
Overall Study Non compliance with protocol	3	5
Overall Study Met Withdrawal Criteria	2	1

Baseline Characteristics

A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MF-DPI n=91 Participants Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=89 Participants Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)	Total n=180 Participants Total of all reporting groups
Age, Customized	91 participants n=5 Participants	89 participants n=7 Participants	180 participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	49 Participants n=7 Participants	92 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.

Outcome measures

Outcome measures
Measure	MF-DPI n=85 Participants Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=87 Participants Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.	-1.09 Percent Change of FEV1 Standard Deviation 10.57	-0.02 Percent Change of FEV1 Standard Deviation 10.17

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.

Outcome measures

Outcome measures
Measure	MF-DPI n=85 Participants Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=87 Participants Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.	-0.11 Percent Change of FVC Standard Deviation 10.91	-0.88 Percent Change of FVC Standard Deviation 11.50

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information.

The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.

Outcome measures

Outcome measures
Measure	MF-DPI n=85 Participants Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=87 Participants Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.	0.01 Percent Change of FEF Standard Deviation 12.68	1.72 Percent Change of FEF Standard Deviation 12.92

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to treat (ITT) population: All randomized patients who have taken at least one dose of study medication and have at least one post-baseline efficacy information. Two participants in the MF-DPI group and three participants in the BUD-DPI group were excluded from the analysis.

The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.

Outcome measures

Outcome measures
Measure	MF-DPI n=83 Participants Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=84 Participants Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.	2.59 Percent Change of AM PEFR Standard Deviation 42.36	1.93 Percent Change of AM PEFR Standard Deviation 71.02

Adverse Events

MF-DPI

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

BUD-DPI

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MF-DPI n=91 participants at risk Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=89 participants at risk Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Infections and infestations cellulitis	2.2% 2/91 • Number of events 2	0.00% 0/89
Investigations pregnancy test positive	0.00% 0/91	1.1% 1/89 • Number of events 1
Musculoskeletal and connective tissue disorders spondylolisthesis	0.00% 0/91	1.1% 1/89 • Number of events 1
Respiratory, thoracic and mediastinal disorders nasal polyps	1.1% 1/91 • Number of events 1	0.00% 0/89

Other adverse events

Other adverse events
Measure	MF-DPI n=91 participants at risk Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)	BUD-DPI n=89 participants at risk Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
Infections and infestations upper respiratory tract infection	14.3% 13/91 • Number of events 14	16.9% 15/89 • Number of events 15

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp and Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place