Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01566149
• Collaborator: (none)
• Enrollment: 49
• Arms: 2
• Duration (Months): 6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability & effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults & adolescents.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI; Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MF/F 200/10 mcg MDI BID Participants receiving MF/F 200/10 mcg MDI twice daily (BID) for 12 weeks	Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI; Two oral inhalations per dose; Other Names: Zenhale® SCH 418131 MK-0887A
Active Comparator: MF/F 400/10 mcg MDI BID Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks	Drug: Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI; Two oral inhalations per dose; Other Names: Zenhale® SCH 418131 MK-0887A

Outcome Measures

Primary Outcome Measures

1. Number of Participants With At Least One Adverse Event (AE) [Up to Week 14]

   An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

2. Number of Participants With At Least One Drug-Related AE [Up to Week 14]

   A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.

3. Number of Participants With At Least One Serious AE [Up to Week 14]

   A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.

4. Number of Participants Who Discontinued From the Study Due to an AE [Up to Week 12]

   An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

Secondary Outcome Measures

1. Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 [Baseline and Week 12]

   Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of asthma of at least 6 months duration

• Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening

• Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)

• If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive

Exclusion Criteria:

• Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months

• Any prior ventilator support for respiratory failure secondary to asthma,

• Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks

• History of a medical condition that, in the investigator's opinion, may interfere with study participation,

• History of smoking within previous year or a cumulative smoking history of more than 10 pack-years

• Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications

• History of use of illicit drugs

• Inability to correctly use an oral MDI

• Pregnant, breastfeeding or plans to become pregnant during study

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: NCT01566149
• Other Study ID Numbers: P08212; MK-0887A-206
• First Posted: Mar 29, 2012
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Asthma; Mometasone Furoate; Formoterol Fumarate; Mometasone Furoate, Formoterol Fumarate Drug Combination

Study Results

Participant Flow

Recruitment Details	Participants were recruited from one study site in Vietnam between March 2012 and September 2012.
Pre-assignment Detail	Participants who were previously on medium-dose asthma medication were assigned to Mometasone Furoate/Formoterol Fumarate (MF/F) 200/10 mcg Metered Dose Inhaler (MDI) twice daily (BID) and participants who were previously on high-dose asthma medication were assigned to MF/F 400/10 mcg MDI BID.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Period Title: Overall Study
STARTED	24	25
COMPLETED	21	23
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID	Total
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks	Total of all reporting groups
Overall Participants	24	25	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.4 (14.48)	41.2 (14.91)	38.3 (14.84)
Sex: Female, Male (Count of Participants)
Female	14 58.3%	12 48%	26 53.1%
Male	10 41.7%	13 52%	23 46.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With At Least One Adverse Event (AE)
Description	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time Frame	Up to Week 14

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Measure Participants	24	25
Number [participants]	5 20.8%	8 32%

2. Primary Outcome

Title	Number of Participants With At Least One Drug-Related AE
Description	A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Time Frame	Up to Week 14

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Measure Participants	24	25
Number [participants]	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With At Least One Serious AE
Description	A serious AE was defined as any untoward medical occurrence or effect that at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.
Time Frame	Up to Week 14

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Measure Participants	24	25
Number [participants]	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Who Discontinued From the Study Due to an AE
Description	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Measure Participants	24	25
Number [participants]	0 0%	1 4%

5. Secondary Outcome

Title	Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Description	Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.

Arm/Group Title	MF/F 200/10 mcg MDI BID	MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks	Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
Measure Participants	24	25
Baseline FEV1	2.397 (0.6824)	2.215 (0.6206)
Week 12 FEV1	2.503 (0.7418)	2.270 (0.6041)
Change from Baseline in FEV1 at Week 12	0.106 (0.2892)	0.054 (0.2055)

Adverse Events

Time Frame	Up to Week 14
Adverse Event Reporting Description	The FAS population consisted of all participants assigned treatment who received at least one dose of study medication.
Arm/Group Title	MF/F 200/10 mcg MDI BID		MF/F 400/10 mcg MDI BID
Arm/Group Description	Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks		Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
All Cause Mortality
	MF/F 200/10 mcg MDI BID		MF/F 400/10 mcg MDI BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MF/F 200/10 mcg MDI BID		MF/F 400/10 mcg MDI BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	MF/F 200/10 mcg MDI BID		MF/F 400/10 mcg MDI BID
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/24 (20.8%)		8/25 (32%)
Infections and infestations
Upper respiratory tract infection	3/24 (12.5%)	4	2/25 (8%)	2
Injury, poisoning and procedural complications
Accidental overdose	1/24 (4.2%)	1	2/25 (8%)	2
Respiratory, thoracic and mediastinal disorders
Asthma	1/24 (4.2%)	1	2/25 (8%)	2
Cough	0/24 (0%)	0	2/25 (8%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.