Bronchodilatory Efficacy of a Single Dose QMF149 (Indacat... | NCT00556673

NCT00556673

ID	Type	Description	Link
2007-002360-10	EudraCT Number

Status Module

Sponsor/Collaborators Module

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indacaterol/mometasone - Placebo	Experimental	In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.	Drug: indacaterol maleate/mometasone furoate Drug: placebo to indacaterol maleate/mometasone furoate Drug: fluticasone proprionate / salmeterol xinafoate
Placebo - indacaterol/mometasone	Experimental	In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twistheler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg / mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.	Drug: indacaterol maleate/mometasone furoate Drug: placebo to indacaterol maleate/mometasone furoate Drug: fluticasone proprionate / salmeterol xinafoate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
indacaterol maleate/mometasone furoate	Drug	Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.	Indacaterol/mometasone - Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.	Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female adult patients aged 18-75 years with persistent asthma
Patients with persistent asthma, diagnosed according to the Global Initiative for Asthma guidelines (GINA) and who additionally met the following criteria:
1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1.
2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50% of the predicted normal value. This criterion for FEV1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist.
3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility test). Reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial.
4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1 pre-dose value had to be at least 85% of the larger value.
Body mass index (BMI) between 18 and 32 kg/m^2 and weight >50 kg.
patients using local contraception

Exclusion Criteria:

Pregnant or nursing women
Recent use of tobacco or history of smoking > 10 pack years
Patients diagnosed with chronic obstructive pulmonary disease (COPD)
Patients with recent experience of severe asthma attack/exacerbation within 6-months of study start
Patients with frequent rescue medication (>8 puffs/day for two consecutive days)
Clinically relevant laboratory abnormality or a clinically significant condition
Active cancer or a history of cancer with less than 5 years disease free survival time
History of long QT syndrome or with long QTc interval prior to dosing
History of hypersensitivity to the study drugs or to drugs with similar chemical structures
Use of certain medications
Use of other investigational drugs
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
History of immunodeficiency diseases, including a positive human immumodeficiency virus (HIV) test result.
History of drug or alcohol abuse or evidence of such abuse

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts/Locations Module

Name	Affiliation	Role
Novartis	Novartis investigator site	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Poitiers		86000	France
Novartis Investigator Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Indacaterol/Mometasone - Placebo	In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Placebo - indacaterol/mometasone

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Indacaterol/Mometasone - Placebo	In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
BG001	Placebo - Indacaterol/Mometasone	In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG00115 BG00231

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00039.1± 11.93 BG00141.5± 7.23 BG00240.3± 9.85

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0009 BG0016 BG002

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

Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.

Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.

Posted

Least Squares Mean

90% Confidence Interval

liters

Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Units	Counts
Participants	OG00024 OG00124 OG00224

Title

Denominators

Categories

Title	Measurements
	OG0000.27(0.19 to 0.36) OG001-0.12(-0.21 to -0.04) OG0020.37(0.28 to 0.47)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.	1-sided		< 0.0001	Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate. A significance level of 5% was used to determine statistical significance.	LS Mean Difference	0.39			2-Sided	90	0.28	0.51				No	Superiority or Other

Secondary

Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

liters

Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Secondary

Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)

Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

Percent of predicted

Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol

Secondary

Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)

Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

Percent of predicted

Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol

Secondary

Change From Period Baseline in Trough Forced Vital Capacity (FVC)

Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

liters

Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Secondary

Change From Period Baseline in Peak Forced Vital Capacity (FVC)

Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

liters

Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Secondary

Change From Period Baseline in Trough FEV1/FVC Ratio

The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

ratio

Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Secondary

Change From Period Baseline in Peak FEV1/FVC Ratio

The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.

Pharmacodynamic population

Posted

Least Squares Mean

90% Confidence Interval

ratio

Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
OG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
OG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Secondary

Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Mean

Standard Deviation

pg*h/mL

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00029

Secondary

Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Mean

Standard Deviation

pg*h/mL

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00029

Secondary

Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Mean

Standard Deviation

pg*h/mL

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00028

Secondary

Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Mean

Standard Deviation

pg/mL

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00029

Secondary

Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Mean

Standard Deviation

pg/mL

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00028

Secondary

Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Median

Full Range

hours

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00029

Secondary

Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol

All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.

Posted

Median

Full Range

hours

Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

ID	Title	Description
OG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.

Units	Counts
Participants	OG00028

Arm/Groups

ID	Title	Description	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Indacaterol/Mometasone	Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.	29	10	29
EG001	Placebo	Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.	28	6	28
EG002	Fluticasone/Salmeterol	Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.	26	2	26

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected29 at risk EG0011 affected28 at risk EG0020 affected26 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Tongue coated	Gastrointestinal disorders	Systematic Assessment	EG0001 affected29 at risk EG0011 affected28 at risk EG0020 affected26 at risk
Catheter site haematoma	General disorders	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0000 affected29 at risk EG0010 affected28 at risk EG0021 affected26 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Rhinitis	Infections and infestations	Systematic Assessment	EG0000 affected29 at risk EG0011 affected28 at risk EG0020 affected26 at risk
Vulvovaginal mycotic infection	Infections and infestations	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Torticollis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 affected29 at risk EG0011 affected28 at risk EG0020 affected26 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0004 affected29 at risk EG0013 affected28 at risk EG0021 affected26 at risk
Restlessness	Psychiatric disorders	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Premenstrual syndrome	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected29 at risk EG0010 affected28 at risk EG0020 affected26 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0005 affected29 at risk EG0011 affected28 at risk EG0020 affected26 at risk

ID	Term
D001249	Asthma

Ancestor Terms

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
D000068656	Mometasone Furoate
C000600413	QMF149
D000068299	Salmeterol Xinafoate

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.

Title

Denominators

Categories

Title	Measurements
	OG000287± 140

Title

Denominators

Categories

Title	Measurements
	OG000389± 191

Title

Denominators

Categories

Title	Measurements
	OG0001331± 712

Title

Denominators

Categories

Title	Measurements
	OG00047.3± 20.9

Title

Denominators

Categories

Title	Measurements
	OG000289± 133

Title

Denominators

Categories

Title	Measurements
	OG0001.05(0.250 to 2.08)

Title

Denominators

Categories

Title	Measurements
	OG0000.325(0.267 to 0.617)