Trial Outcomes & Findings for Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED) (NCT NCT00383552)

Last Updated: 2024-05-17

Results Overview

Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

746 participants

Primary outcome timeframe

Week 26

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	MF/F MDI 100/10 mcg BID Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID Placebo twice daily (BID)
Overall Study STARTED	182	188	188	188
Overall Study COMPLETED	146	147	127	116
Overall Study NOT COMPLETED	36	41	61	72

Reasons for withdrawal

Reasons for withdrawal
Measure	MF/F MDI 100/10 mcg BID Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID Placebo twice daily (BID)
Overall Study Adverse Event	7	6	9	6
Overall Study Lack of Efficacy	4	13	29	42
Overall Study Lost to Follow-up	0	1	5	1
Overall Study Did not wish to continue (unrelated)	4	9	5	6
Overall Study Did not wish to continue (related)	1	0	2	3
Overall Study Noncompliance with the protocol	11	6	8	10
Overall Study Did not meet protocol eligibility	8	6	2	3
Overall Study Administrative	1	0	1	1

Baseline Characteristics

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MF/F MDI 100/10 mcg BID n=182 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=188 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=188 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=188 Participants Placebo twice daily (BID)	Total n=746 Participants Total of all reporting groups
Age, Continuous	37.1 years STANDARD_DEVIATION 16.9 • n=5 Participants	39.4 years STANDARD_DEVIATION 16.7 • n=7 Participants	38.5 years STANDARD_DEVIATION 15.6 • n=5 Participants	38.1 years STANDARD_DEVIATION 17.4 • n=4 Participants	38.3 years STANDARD_DEVIATION 16.6 • n=21 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	105 Participants n=7 Participants	103 Participants n=5 Participants	106 Participants n=4 Participants	413 Participants n=21 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	83 Participants n=7 Participants	85 Participants n=5 Participants	82 Participants n=4 Participants	333 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=155 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=156 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=146 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=129 Participants Placebo twice daily (BID)
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) Baseline	3.94 liters * hours Standard Deviation 3.29	1.85 liters * hours Standard Deviation 3.29	4.09 liters * hours Standard Deviation 3.29	1.64 liters * hours Standard Deviation 3.29
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) Change from Baseline	4.00 liters * hours Standard Deviation 3.71	2.53 liters * hours Standard Deviation 3.71	3.83 liters * hours Standard Deviation 3.71	1.11 liters * hours Standard Deviation 3.71

PRIMARY outcome

Timeframe: Across the 26 week treatment period

Population: Medians for time-to-event outcomes are estimated for those who had events.

Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=30 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=53 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=84 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=86 Participants Placebo twice daily (BID)
Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period	45.5 Days Inter-Quartile Range 101 • Interval 11.0 to 101.0	54 Days Inter-Quartile Range 98 • Interval 12.0 to 98.0	51.5 Days Inter-Quartile Range 125.5 • Interval 16.5 to 125.5	27.5 Days Inter-Quartile Range 87 • Interval 8.0 to 87.0

PRIMARY outcome

Timeframe: Week 26

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=155 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=156 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=146 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=129 Participants Placebo twice daily (BID)
Number of Participants With at Least One Severe Asthma Exacerbation at Week 26	30 participants	53 participants	84 participants	86 participants

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=143 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=145 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=129 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=116 Participants Placebo twice daily (BID)
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score Baseline	1.34 units on a scale Standard Deviation 0.71	1.29 units on a scale Standard Deviation 0.60	1.38 units on a scale Standard Deviation 0.76	1.23 units on a scale Standard Deviation 0.71
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score Change from Baseline	-0.40 units on a scale Standard Deviation 0.65	-0.32 units on a scale Standard Deviation 0.65	-0.12 units on a scale Standard Deviation 0.65	-0.11 units on a scale Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=144 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=147 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=129 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=117 Participants Placebo twice daily (BID)
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score Baseline	5.60 units on a scale Standard Deviation 0.93	5.65 units on a scale Standard Deviation 1.00	5.60 units on a scale Standard Deviation 0.98	5.76 units on a scale Standard Deviation 1.02
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score Change from Baseline	0.44 units on a scale Standard Deviation 0.73	0.39 units on a scale Standard Deviation 0.73	0.15 units on a scale Standard Deviation 0.73	0.06 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: Baseline to Endpoint

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=181 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=185 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=185 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=188 Participants Placebo twice daily (BID)
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA) Change from Baseline	-0.06 Proportion of Nights Standard Deviation 0.16	-0.03 Proportion of Nights Standard Deviation 0.16	-0.03 Proportion of Nights Standard Deviation 0.16	0.02 Proportion of Nights Standard Deviation 0.16
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA) Baseline	0.13 Proportion of Nights Standard Deviation 0.12	0.12 Proportion of Nights Standard Deviation 0.12	0.15 Proportion of Nights Standard Deviation 0.15	0.13 Proportion of Nights Standard Deviation 0.14

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=160 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=163 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=160 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=137 Participants Placebo twice daily (BID)
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12 Baseline	2.50 liters Standard Deviation 2.56	2.41 liters Standard Deviation 2.46	2.47 liters Standard Deviation 2.52	2.46 liters Standard Deviation 2.50
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12 Change from Baseline	0.18 liters Standard Deviation 0.21	0.16 liters Standard Deviation 0.21	0.11 liters Standard Deviation 0.21	0.04 liters Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Efficacy analyses were based on randomized participants with Baseline and any post-baseline data (intent-to-treat principle).

The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled.

Outcome measures

Outcome measures
Measure	MF/F MDI 100/10 mcg BID n=155 Participants Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)	MF MDI 100 mcg BID n=156 Participants Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)	F MDI 10 mcg BID n=146 Participants Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)	Placebo BID n=128 Participants Placebo twice daily (BID)
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup Less than 25	5.24 liters * hours Standard Deviation 4.42	3.19 liters * hours Standard Deviation 4.42	4.34 liters * hours Standard Deviation 4.42	2.22 liters * hours Standard Deviation 4.42
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup 25 to less than 30	3.36 liters * hours Standard Deviation 4.14	3.23 liters * hours Standard Deviation 4.14	4.26 liters * hours Standard Deviation 4.14	1.22 liters * hours Standard Deviation 4.14
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup 30 or more	3.35 liters * hours Standard Deviation 3.68	1.69 liters * hours Standard Deviation 3.68	3.13 liters * hours Standard Deviation 3.68	-0.73 liters * hours Standard Deviation 3.68

Adverse Events

OL MF MDI 100 MCG BID

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

MF/F MDI 100/10 MCG BID

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

MF MDI 100 MCG BID

Serious events: 5 serious events

Other events: 37 other events

Deaths: 0 deaths

F MDI 10 MCG BID

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

PLACEBO

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OL MF MDI 100 MCG BID n=882 participants at risk Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.	MF/F MDI 100/10 MCG BID n=182 participants at risk	MF MDI 100 MCG BID n=188 participants at risk	F MDI 10 MCG BID n=188 participants at risk	PLACEBO n=188 participants at risk
Cardiac disorders PULMONARY VALVE STENOSIS	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.55% 1/182 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Ear and labyrinth disorders DEAFNESS	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Endocrine disorders GOITRE	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.55% 1/182 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
General disorders ASTHENIA	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Infections and infestations APPENDICITIS	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Infections and infestations VIRAL PERICARDITIS	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.55% 1/182 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Reproductive system and breast disorders DYSFUNCTIONAL UTERINE BLEEDING	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.55% 1/182 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Reproductive system and breast disorders FALLOPIAN TUBE CYST	0.11% 1/882 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.11% 1/882 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.55% 1/182 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Vascular disorders HYPERTENSION	0.00% 0/882 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/182 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.53% 1/188 • Number of events 1 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	0.00% 0/188 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.

Other adverse events

Other adverse events
Measure	OL MF MDI 100 MCG BID n=882 participants at risk Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.	MF/F MDI 100/10 MCG BID n=182 participants at risk	MF MDI 100 MCG BID n=188 participants at risk	F MDI 10 MCG BID n=188 participants at risk	PLACEBO n=188 participants at risk
Infections and infestations NASOPHARYNGITIS	0.34% 3/882 • Number of events 3 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	9.3% 17/182 • Number of events 19 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	6.9% 13/188 • Number of events 15 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	3.7% 7/188 • Number of events 7 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	2.7% 5/188 • Number of events 5 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.57% 5/882 • Number of events 5 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	5.5% 10/182 • Number of events 11 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	9.0% 17/188 • Number of events 19 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	10.6% 20/188 • Number of events 26 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	6.4% 12/188 • Number of events 17 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.
Nervous system disorders HEADACHE	1.7% 15/882 • Number of events 18 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	6.6% 12/182 • Number of events 17 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	5.9% 11/188 • Number of events 18 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	4.8% 9/188 • Number of events 9 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.	3.7% 7/188 • Number of events 10 All participants treated with OL MF MDI and/or double-blind study medication are included in the safety population.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

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