Safety and Efficacy of Mometasone Furoate Delivered Via C... | NCT01555151

NCT01555151

ID	Type	Description	Link
2011-005100-14	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mometasone furoate 80 μg	Experimental	Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.	Drug: Mometasone furoate Device: Concept 1
Mometasone furoate 200 µg	Experimental	Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.	Drug: Mometasone furoate Device: Twisthaler
Mometasone furoate 320 µg	Experimental	Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.	Drug: Mometasone furoate Device: Concept 1
Mometasone furoate 800 µg	Experimental	Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mometasone furoate	Drug	Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1)	Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.	Day 29

Secondary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment	Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.	Days 8, 15 and 22

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females who were ≥ 12 years old at the time informed consent was obtained
Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria
Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).
Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).
Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).
Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.
Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

Key exclusion criteria included:

Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010.
Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.
Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
Patients who have ever required intubation for a severe asthma attack/exacerbation.
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

Other protocol-defined inclusion/exclusion criteria may apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Kortrijk	Belgium	8500	Belgium
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
FG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
BG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
BG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
BG003	Mometasone Furoate 800 ug Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
BG004	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Trough Forced Expiratory Volume in 1 Second (FEV1)

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Liters

Day 29

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening

Units	Counts
Participants	OG000171 OG001165 OG002172 OG003

Title

Denominators

Categories

Title	Measurements
	OG0002.139± 0.0281 OG0012.071± 0.0283 OG0022.187± 0.0281 OG003

Secondary

Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment

Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Liters

Days 8, 15 and 22

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device

Secondary

Forced Vital Capacity (FVC) at All Time Points

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Liters

Days 1, 8, 15, 22, 28 and 29 at all time points

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening

Secondary

Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points

The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Liters per second

Days 1, 8, 15, 22, 28 and 29 at all time points

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device

Secondary

Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points

Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Percent

Days 1, 8, 15, 22, 28 and 29 at all time points

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device

Secondary

Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment

Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Liters per min

Baseline and week 4

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening

Secondary

Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit

Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

Units on a scale

Baseline, days 8,15,22 and 29

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device

Secondary

Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment

Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

number of puffs

Baseline and 4 weeks

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device

Secondary

Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment

Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.

A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.

The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Least Squares Mean

Standard Error

percentage days

4 weeks

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device

Secondary

Fractional Exhaled Nitric Oxide (FeNO)

FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.

The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.

Posted

Mean

Standard Error

ppm

Days 15 and 29

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening

Secondary

Plasma Cortisol Concentrations

Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L

The safety set includes all subjects who received at least one dose of study drug.

Posted

Mean

Standard Deviation

nmol/L

Baseline, days 1 and 28

ID	Title	Description
OG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
OG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
OG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
OG003	Mometasone Furoate 800 ug Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mometasone Furoate 80 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening	0	186	13	186
EG001	Mometasone Furoate 200 ug Daily Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening	0	180	17	180
EG002	Mometasone Furoate 320 ug Daily Via the Concept1 Device	Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening	1	183	15	183
EG003	Mometasone Furoate 800 ug Via the Twisthaler® Device	Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening	0	186	8	186
EG004	Total	Total	1	735	53	735

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected186 at risk EG0017 affected180 at risk EG0026 affected183 at risk EG0032 affected186 at risk EG00418 affected735 at risk
Blood cortisol decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0004 affected186 at risk EG0013 affected180 at risk EG0025 affected183 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected186 at risk EG0015 affected180 at risk EG0025 affected183 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected186 at risk EG0014 affected180 at risk EG0021 affected183 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected186 at risk EG0010 affected180 at risk EG0021 affected183 at risk EG0030 affected186 at risk EG0041 affected735 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected186 at risk EG0010 affected180 at risk EG0021 affected183 at risk EG003