Asthma Study Comparing Anti-Inflammatory Effects of 3 Doses of Mometasone Furoate/Formoterol Fumarate and Medium Dose Mometasone Furoate (Study P05122 AM1)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00635882
• Collaborator: (none)
• Enrollment: 93
• Arms: 6
• Duration (Months): 16

Study Details

Study Description

Brief Summary

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) formulation and medium dose mometasone furoate (MF) dry powder inhaler (DPI) and MDI formulations in adults and adolescents with persistent allergic asthma.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Airway Inflammation	Drug: mometasone furoate/formoterol 100/10 mcg; Drug: mometasone furoate/formoterol 200/10 mcg; Drug: mometasone furoate/formoterol 400/10 mcg; Drug: MF DPI 200 mcg; Drug: MF MDI 200 mcg; Drug: Placebo	Phase 2

Detailed Description

This is a 2-week double-blind, placebo-controlled, parallel group study comparing the anti-inflammatory effects of low, medium, and high dose mometasone furoate/formoterol fumarate MDI formulation and medium dose mometasone furoate (MF) DPI and MDI formulations in adults and adolescents with persistent allergic asthma. An open-label run in period is to be followed by a double-blind treatment period.

A total of 90 subjects (15 per treatment) will be enrolled to ensure 12 subjects per treatment at the Day 14 evaluation, accounting for a 20% drop-out rate. A sample size of 12 subjects per treatment is required to detect a treatment difference of 28% in percent change of eNO at Day 14, assuming a pooled standard deviation of 20% with a power of 90%. These estimates are based on examination of eNO levels in asthmatic vs healthy subjects in an article written by S.A. Kharitonov et. al, 2003.

Subjects will be randomized to one of six treatment groups (MF/F MDI 100/10 mcg BID, MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, MF DPI 200 mcg BID, MF MDI 200 mcg BID, or Placebo MDI BID) according to an Schering-Plough Research Institute (SPRI) computer-generated randomization schedule. Randomization will be performed in appropriately sized blocks using random numbers generated by statistical analysis software (SAS).

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti-Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adults and Adolescents With Persistent Allergic Asthma
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MF/F MDI 100/10 mcg	Drug: mometasone furoate/formoterol 100/10 mcg; mometasone furoate/formoterol 100/10 mcg twice daily (BID) (two inhalations of MF/F 50/5 from a metered-dose inhaler) for 14 days; Other Names: MF/F (SCH 418131)
Experimental: MF/F MDI 200/10 mcg	Drug: mometasone furoate/formoterol 200/10 mcg; mometasone furoate/formoterol 200/10 mcg twice daily (BID) (two inhalations of MF/F 100/5 from a metered-dose inhaler) for 14 days; Other Names: MF/F 200/10 (SCH 418131)
Experimental: MF/F MDI 400/10 mcg	Drug: mometasone furoate/formoterol 400/10 mcg; mometasone furoate/formoterol 400/10 mcg twice daily (BID) (two inhalations of MF/F 200/5 mcg from a metered-dose inhaler) for 14 days; Other Names: MF/F 400/10 (SCH 418131)
Experimental: MF DPI 200 mcg	Drug: MF DPI 200 mcg; MF DPI 200 mcg twice daily (BID) (one inhalation of MF DPI 200 mcg) for 14 days; Other Names: mometasone furoate (SCH 32088)
Experimental: MF MDI 200 mcg	Drug: MF MDI 200 mcg; MF MDI 200 mcg twice daily (BID) (two inhalations of MF MDI 100 mcg) for 14 days; Other Names: mometasone furoate (SCH 32088)
Experimental: Placebo	Drug: Placebo; MF/F MDI placebo twice daily (BID) (2 inhalations)

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) [Baseline to Day 14]

Secondary Outcome Measures

1. Mean Percent Change From Baseline to Day 7 in eNO Ppb [Baseline to Day 7]

2. Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage) [Baseline to Day 14]

3. Mean Change From Baseline to Day 15 of Mannitol Challenge [Baseline to Day 15]

   Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).

4. Change From Baseline in AM Total Asthma Symptom Score at Days 2-15 [Baseline and Days 2-15]

   Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.

5. Change From Baseline in PM Total Asthma Symptom Score at Days 1-15 [Baseline and Days 1-15]

   Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.

6. Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15 [Baseline and Days 2-15]

7. Change From Baseline in PM PEF at Days 1-15 [Baseline and Days 1-15]

Other Outcome Measures

1. Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• To document asthma diagnosis, historical reversibility defined as an increase in absolute forced expiratory volume (in liters) in 1 second (FEV1) of >= 12% and >= 200 mL must have been performed within 12 months of Screening. For subjects without historical reversibility, one of the following methods can be used at the Screening

Visit or at any time before the Baseline Visit:

• Demonstration of an increase in absolute FEV1 of at least 12% and a volume increase of at least 200 mL within 15-20 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose 360 to 400 mcg) or of nebulized short-acting beta agonist (SABA) (2.5 mg), if confirmed as standard office practice, OR

• Demonstration of a peak expiratory flow (PEF) variability of more than 20% expressed as a percentage of the mean highest and lowest morning prebronchodilator PEF over at least 1 week, OR

• Demonstration of a diurnal variation PEF of more than 20% based on the difference between the prebronchodilator (before taking albuterol/salbutamol) morning value and the postbronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period. {The calculation formula: Diurnal PEF Variation = Absolute [(highest of 3 readings, PM Post-bronchodilator (BD) PEF from prior evening) - (highest of 3 readings, AM Pre-BD from morning value)]/[(highest PM Post-BD + highest AM Pre-BD)/2] * 100}

• At Screening and Baseline Visits, a subject must have persistent allergic asthma with an FEV1 >65% predicted.

• A subject must be allergic to at least one common allergen (grasses, trees, weeds, house dust mites, molds, dog and cat) as demonstrated by clinical symptoms when exposed to the allergen(s), and by skin prick testing or a radioallergosorbent (RAST) class >1 (excluding modified RAST procedure [mRAST]) within 2 years of inclusion in the study.

• If, based upon the medical judgment of the investigator, there is no inherent harm in changing the subject's current asthma therapy, the subject and/or parent/guardian) must agree to discontinue prescribed inhaled corticosteroid (ICS), anticholinergics, leukotriene receptor inhibitors, and long-acting beta-2 agonists at the Screening Visit as per required washouts, and be transferred to treatment with SABA for relief for 2 weeks before the Baseline/Randomization Visit.

• Clinical laboratory tests (complete blood count, blood chemistries, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator.

• An electrocardiogram (ECG) performed at the Screening Visit or within 30 days prior to Screening Visit must be clinically acceptable to the investigator and have a QTc interval <440 milliseconds for males and <450 msec for females.

• At Screening or any time prior to Baseline, a subject must have an eNO level of >30 parts per billion (ppb) at a flow rate of 50 mL/second.

• At Screening or any time before Baseline, a subject must have a sputum eosinophil count >3% of total cell count.

• Willingness to give written informed consent and ability to adhere to dose and visit schedules. A subject 12 to 17 years of age must also provide written assent.

• A nonpregnant female subject of childbearing potential (with a negative serum pregnancy test at Screening) must use a medically acceptable, adequate form of birth control. If not currently sexually active she must agree to use a double-barrier method if she becomes sexually active during the study.

Exclusion Criteria:

• Use of systemic glucocorticosteroids within 3 months before Screening.

• Upper or lower respiratory tract infection within 4 weeks before Screening.

• Decrease in absolute FEV1 >20% between Screening and Baseline Visits.

• Requirement for > 8 inhalations per day of SABA MDI, or 2 or more nebulized treatments of 2.5 mg SABA, on any 2 consecutive days between the Screening and Baseline Visits.

• A decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days before Baseline. At Visit 1, the Run-in Period stability limit for PEF will be established based on the subject's personal best. If the subject does not have a historical personal best, the historical PEF measurement will be the PEF predicted based on the subject's sex, age, and height. PEF value to be multiplied by 0.70 to determine stability limit.

• A clinical asthma exacerbation defined as a clinical deterioration of asthma that results in emergency treatment, hospitalization for asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids but allowing SABA), as per investigator, between Screening and Baseline Visits.

• Inability to induce sputum after 1 or 2 trys.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00635882
• Other Study ID Numbers: P05122
• First Posted: Mar 14, 2008
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Organon and Co: mometasone; formoterol
• Additional relevant MeSH terms: Asthma; Inflammation; Mometasone Furoate; Formoterol Fumarate

Study Results

Participant Flow

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Period Title: Overall Study
STARTED	20	17	12	15	16	13
COMPLETED	19	17	12	15	16	13
NOT COMPLETED	1	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo	Total
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days	Total of all reporting groups
Overall Participants	20	17	12	15	16	13	93
Age, Customized (participants) [Number]
18 to <65 years	20 100%	14 82.4%	11 91.7%	15 100%	16 100%	11 84.6%	87 93.5%
> or = to 65 years	0 0%	3 17.6%	1 8.3%	0 0%	0 0%	2 15.4%	6 6.5%
Sex: Female, Male (Count of Participants)
Female	13 65%	10 58.8%	4 33.3%	6 40%	6 37.5%	8 61.5%	47 50.5%
Male	7 35%	7 41.2%	8 66.7%	9 60%	10 62.5%	5 38.5%	46 49.5%

Outcome Measures

1. Primary Outcome

Title	Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
Time Frame	Baseline to Day 14

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	19	16	12	14	15	13
Mean (Standard Deviation) [percentage of eNO]	-35.3 (40.3)	-45.4 (40.3)	-61.4 (40.3)	-51.3 (40.3)	-46.1 (40.3)	0.1 (40.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Mean Percent Change From Baseline to Day 7 in eNO Ppb
Time Frame	Baseline to Day 7

Outcome Measure Data

Analysis Population Description

All Randomized Participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	19	16	12	14	15	13
Mean (Standard Deviation) [percentage of eNO]	-37.9 (36.3)	-39.7 (36.3)	-45.6 (36.3)	-46.0 (36.3)	-37.2 (36.3)	4.8 (36.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eNO as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)
Time Frame	Baseline to Day 14

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	15	13	7	12	11	10
Mean (Standard Deviation) [percentage of Sputum Eosinophil Count]	21.1 (127.6)	-35.5 (127.6)	-75.4 (127.6)	-55.3 (127.6)	-33.7 (127.6)	71.7 (127.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eosinophils as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eosinophils as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	ANCOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline eosinophils as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.336
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Mean Change From Baseline to Day 15 of Mannitol Challenge
Description	Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1).
Time Frame	Baseline to Day 15

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	12	9	6	8	9	9
Baseline	102.2 (106.7)	48.6 (106.7)	67.9 (106.7)	137.6 (106.7)	126.0 (106.7)	159.4 (106.7)
Mean Change from Baseline to Day 15	176.6 (264)	153.8 (264)	162.9 (264)	159.4 (264)	146.2 (264)	-63.7 (264)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline PD15 as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.120
	Comments
	Method	ANCOVA
	Comments	Analysis applies to Mean Change from Baseline to Day 15.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline PD15 as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.103
	Comments
	Method	ANCOVA
	Comments	Analysis applies to Mean Change from Baseline to Day 15.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	ANCOVA model with treatment and baseline PD15 as a covariate was used. Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	ANCOVA
	Comments	Analysis applies to Mean Change from Baseline to Day 15.

5. Secondary Outcome

Title	Change From Baseline in AM Total Asthma Symptom Score at Days 2-15
Description	Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.
Time Frame	Baseline and Days 2-15

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	20	17	12	15	16	13
Baseline	1.6 (1.66)	1.2 (1.66)	2.2 (1.66)	1.5 (1.66)	1.1 (1.66)	1.4 (1.66)
Mean Change from Baseline to Days 2-15	-0.7 (1.28)	-0.7 (1.28)	-1.5 (1.28)	-1.2 (1.28)	-0.5 (1.28)	-0.2 (1.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	One-way analysis of variance (ANOVA) model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.261
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.334
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

6. Secondary Outcome

Title	Change From Baseline in PM Total Asthma Symptom Score at Days 1-15
Description	Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary.
Time Frame	Baseline and Days 1-15

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	20	17	12	15	15	13
Baseline	1.7 (1.62)	1.1 (1.62)	2.1 (1.62)	1.6 (1.62)	1.6 (1.62)	1.7 (1.62)
Mean Change from Baseline to Days 1-15	-0.4 (1.24)	-0.6 (1.24)	-1.4 (1.24)	-1.1 (1.24)	-0.7 (1.24)	-0.3 (1.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.037
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.643
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.963
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

7. Secondary Outcome

Title	Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15
Time Frame	Baseline and Days 2-15

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	20	17	12	15	16	13
Baseline	452.6 (112.1)	421.2 (112.1)	468.7 (112.1)	466.3 (112.1)	473.3 (112.1)	413.2 (112.1)
Mean Change from Baseline to Days 2-15	48.1 (47.0)	46.9 (47.0)	69.8 (47.0)	30.3 (47.0)	30.8 (47.0)	-9.0 (47.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 2-15.

8. Secondary Outcome

Title	Change From Baseline in PM PEF at Days 1-15
Time Frame	Baseline and Days 1-15

Outcome Measure Data

Analysis Population Description

All randomized participants

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	20	17	12	15	15	13
Baseline	462.0 (114.6)	437.2 (114.6)	486.7 (114.6)	484.4 (114.6)	472.5 (114.6)	422.7 (114.6)
Mean Change from Baseline to Days 1-15	47.7 (42.3)	34.5 (42.3)	66.8 (42.3)	20.2 (42.3)	28.3 (42.3)	4.5 (42.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 400/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 200/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.057
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	MF/F MDI 100/10 mcg, Placebo
	Comments	One-way ANOVA model with treatment effect was used. Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANOVA
	Comments	Analysis applies to Mean Change from Baseline to Days 1-15.

9. Other Pre-specified Outcome

Title	Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MF/F MDI 100/10 mcg	MF/F MDI 200/10 mcg	MF/F MDI 400/10 mcg	MF DPI 200 mcg	MF MDI 200 mcg	Placebo
Arm/Group Description	Mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID) for 14 days	MF/F MDI 200/10 mcg BID for 14 days	MF/F MDI 400/10 mcg BID for 14 days	Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg BID for 14 days	MF MDI 200 mcg BID for 14 days	Placebo MDI BID for 14 days
Measure Participants	19	16	12	14	15	13
Mean (Standard Deviation) [ppb]	54.8 (40.8)	70.0 (40.8)	77.1 (40.8)	102.6 (40.8)	66.2 (40.8)	79.6 (40.8)

Adverse Events

Arm/Group Title	MF/F MDI 100/10 MCG BID		MF/F MDI 200/10 MCG BID		MF/F MDI 400/10 MCG BID		MF DPI 200 MCG BID		MF MDI 200 MCG BID		PLACEBO
Arm/Group Description
All Cause Mortality
	MF/F MDI 100/10 MCG BID		MF/F MDI 200/10 MCG BID		MF/F MDI 400/10 MCG BID		MF DPI 200 MCG BID		MF MDI 200 MCG BID		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	MF/F MDI 100/10 MCG BID		MF/F MDI 200/10 MCG BID		MF/F MDI 400/10 MCG BID		MF DPI 200 MCG BID		MF MDI 200 MCG BID		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/17 (0%)		0/12 (0%)		0/15 (0%)		0/16 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	MF/F MDI 100/10 MCG BID		MF/F MDI 200/10 MCG BID		MF/F MDI 400/10 MCG BID		MF DPI 200 MCG BID		MF MDI 200 MCG BID		PLACEBO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		8/17 (47.1%)		1/12 (8.3%)		2/15 (13.3%)		6/16 (37.5%)		2/13 (15.4%)
Ear and labyrinth disorders
EAR DISCOMFORT	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
INGUINAL HERNIA	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
General disorders
PYREXIA	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
Infections and infestations
NASOPHARYNGITIS	1/20 (5%)	1	2/17 (11.8%)	2	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
ORAL CANDIDIASIS	0/20 (0%)	0	0/17 (0%)	0	1/12 (8.3%)	1	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
UPPER RESPIRATORY TRACT INFECTION	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0
Injury, poisoning and procedural complications
SPINAL CORD INJURY	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0
SUNBURN	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
Nervous system disorders
DIZZINESS	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	3	0/13 (0%)	0
HEADACHE	0/20 (0%)	0	2/17 (11.8%)	3	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
COUGH	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	1/13 (7.7%)	1
DRY THROAT	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
DYSPHONIA	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	1/15 (6.7%)	1	0/16 (0%)	0	0/13 (0%)	0
NASAL CONGESTION	1/20 (5%)	1	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
OROPHARYNGEAL PAIN	1/20 (5%)	1	2/17 (11.8%)	2	0/12 (0%)	0	0/15 (0%)	0	2/16 (12.5%)	2	1/13 (7.7%)	1
RHINITIS ALLERGIC	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
THROAT IRRITATION	0/20 (0%)	0	1/17 (5.9%)	1	0/12 (0%)	0	0/15 (0%)	0	0/16 (0%)	0	0/13 (0%)	0
Skin and subcutaneous tissue disorders
PAIN OF SKIN	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0
PRURITUS	0/20 (0%)	0	0/17 (0%)	0	0/12 (0%)	0	0/15 (0%)	0	1/16 (6.3%)	1	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.