Single Dose Study to Assess Efficacy and Safety of 4 Dose... | NCT01425814

ID	Type	Description	Link
LBC25

Single Dose Study to Assess Efficacy and Safety of 4 Dose... | NCT01425814 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm #2	Experimental	Single dose, double blind treatment period	Drug: LAS100977
Arm #3	Experimental	Single dose, double blind treatment period	Drug: LAS100977
Arm #4	Experimental	Single dose, double blind treatment period	Drug: LAS100977
Arm #5	Active Comparator	Single dose, double blind treatment period	Drug: Reference
Arm #6	Placebo Comparator	Single dose, double blind treatment period	Drug: Placebo
Arm #1	Experimental	Single dose, double blind treatment period	Drug: LAS100977

Name	Type	Description	Arm Group Labels	Other Names
LAS100977	Drug	Dry powder inhalation,Once daily, single dose	Arm #1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected	Day 2

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

Contacts/Locations Module

Name	Affiliation	Role
Carol Astbury, PhD	AstraZeneca	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Almirall Investigational Sites#5		Berlin		14050	Germany
Almirall Investigational Sites#2

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27439370	Derived	Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting beta2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD. BMC Pulm Med. 2016 Jul 20;16(1):102. doi: 10.1186/s12890-016-0266-5.

Label	URL
CSR Synopsis	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequence A	Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
FG001	Sequence B	LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Period 2

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG00110 subjects FG00212 subjects FG00310 subjects FG00412 subjects FG00513 subjects
COMPLETED		FG00012 subjects FG0019 subjects FG00212 subjects FG00310 subjects FG004
NOT COMPLETED		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Stability criteria not fulfilled		FG0000 subjects FG0011 subjects FG0020 subjects FG003

Period 3

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG0019 subjects FG00212 subjects FG00310 subjects FG00412 subjects FG00513 subjects
COMPLETED		FG00012 subjects FG0019 subjects FG00212 subjects FG00310 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Period 4

Type	Comment	Milestone Data
STARTED		FG00012 subjects FG0019 subjects FG00212 subjects FG00310 subjects FG00412 subjects FG00512 subjects
COMPLETED		FG00011 subjects FG0019 subjects FG00211 subjects FG00310 subjects FG004
NOT COMPLETED		FG0001 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects FG0021 subjects FG003

Period 5

Type	Comment	Milestone Data
STARTED		FG00011 subjects FG0019 subjects FG00211 subjects FG00310 subjects FG00412 subjects FG00512 subjects
COMPLETED		FG00011 subjects FG0019 subjects FG00210 subjects FG00310 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects FG004

Type	Comment	Reasons
Stability criteria not fulfilled		FG0000 subjects FG0010 subjects FG0021 subjects FG003

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
	BG00061.2± 7.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00026
Male	BG00044

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 Baseline in Trough Forced Expiratory Volume in One Second (FEV1)

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device
OG004	LAS100977 10 μg	Single dose administered by inhalation from the Genuair® device
OG005	Indacaterol 150 μg	Single dose administered by inhalation from the Breezhaler® inhaler

Units	Counts
Participants	OG00068 OG00167 OG00266 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.035± 0.024 OG0010.066± 0.024 OG0020.168± 0.024 OG003

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 OG004		ANCOVA		<0.0001		Least Squares Mean Difference	0.259	Standard Error of the Mean	0.020	2-Sided	95	0.219	0.298					Superiority or Other
OG000 OG003		ANCOVA		<0.0001

Secondary

Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

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

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

Absolute Forced Expiratory Volume in One Second (FEV1) Values

At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device

Secondary

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

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

Time to Peak Forced Expiratory Volume in One Second (FEV1)

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Mean

Standard Error

Hours

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device

Secondary

Change From Baseline in Trough Forced Vital Capacity (FVC)

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device

Secondary

Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

Change From Baseline in Forced Vital Capacity (FVC)

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

Absolute Forced Vital Capacity (FVC) Values

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device

Secondary

Change From Baseline in Peak Forced Vital Capacity (FVC)

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003

Secondary

Time to Peak Forced Vital Capacity (FVC)

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Mean

Standard Error

Hours

Day 1

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device

Secondary

Change From Baseline in Inspiratory Capacity (IC)

Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg

Secondary

Absolute Inspiratory Capacity (IC) Values

At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS

ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period

Posted

Least Squares Mean

Standard Error

Liters

Up to Day 2

ID	Title	Description
OG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
OG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device
OG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device
OG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler	0	68	2	68
EG001	LAS100977 0.625 μg	Single dose administered by inhalation from the Genuair® device	0	67	4	67
EG002	LAS100977 2.5 μg	Single dose administered by inhalation from the Genuair® device	0	66	1	66
EG003	LAS100977 5 μg	Single dose administered by inhalation from the Genuair® device	1	66	1	66
EG004	LAS100977 10 μg	Single dose administered by inhalation from the Genuair® device	1	67	2	67
EG005	Indacaterol 150 μg	Single dose administered by inhalation from the Breezhaler® inhaler	0	68	5	68

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	MedDRA Version 14.1	Systematic Assessment		EG0000 affected68 at risk EG0010 affected67 at risk EG0020 affected66 at risk EG0031 affected66 at risk EG004
Dizziness	Nervous system disorders	MedDRA Version 14.1	Systematic Assessment		EG0000 affected68 at risk EG0010 affected67 at risk EG0020 affected66 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA Version 14.1	Systematic Assessment		EG0002 affected68 at risk EG0014 affected67 at risk EG0021 affected66 at risk EG0031 affected66 at risk EG0042 affected67 at risk EG0055 affected68 at risk

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Title

Denominators

Categories

Change from baseline in FEV1 AUC0-12

Title	Measurements
	OG000-0.003± 0.012 OG0010.168± 0.021 OG0020.243± 0.021 OG0030.247± 0.021 OG0040.288± 0.022 OG0050.134± 0.017

Change from baseline in FEV1 AUC0-24

Title	Measurements
	OG000-0.032± 0.013 OG0010.121± 0.021 OG0020.205± 0.022 OG003

Change from baseline in FEV1 AUC12-24

Title	Measurements
	OG000-0.062± 0.016 OG0010.077± 0.023 OG0020.166± 0.024 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0001.475± 0.059 OG0011.506± 0.065 OG0021.472± 0.062 OG0031.483± 0.063 OG0041.493± 0.065 OG0051.488± 0.064

Day 1 0.08 hr

Title	Measurements
	OG000-0.005± 0.013 OG0010.044± 0.011 OG0020.090± 0.011 OG003

Day 1 0.25 hr

Title	Measurements
	OG0000.006± 0.013 OG0010.087± 0.016 OG0020.155± 0.015 OG003

Day 1 0.5 hr

Title	Measurements
	OG0000.018± 0.015 OG0010.126± 0.019 OG0020.186± 0.018 OG003

Day 1 1 hr

Title	Measurements
	OG0000.010± 0.015 OG0010.151± 0.020 OG0020.217± 0.021 OG003

Day 1 2 hr

Title	Measurements
	OG0000.002± 0.016 OG0010.166± 0.022 OG0020.230± 0.021 OG003

Day 1 3 hr

Title	Measurements
	OG0000.018± 0.014 OG0010.201± 0.022 OG0020.287± 0.022 OG003

Day 1 4 hr

Title	Measurements
	OG0000.015± 0.014 OG0010.225± 0.021 OG0020.308± 0.023 OG003

Day 1 6 hr

Title	Measurements
	OG000-0.005± 0.017 OG0010.216± 0.028 OG0020.276± 0.024 OG003

Day 1 8 hr

Title	Measurements
	OG0000.007± 0.016 OG0010.169± 0.025 OG0020.260± 0.025 OG003

Day 1 12 hr

Title	Measurements
	OG000-0.047± 0.017 OG0010.115± 0.025 OG0020.189± 0.027 OG003

Day 1 14 hr

Title	Measurements
	OG000-0.067± 0.020 OG0010.099± 0.026 OG0020.180± 0.026 OG003

Day 2 23 hr

Title	Measurements
	OG000-0.066± 0.017 OG0010.036± 0.023 OG0020.134± 0.026 OG003

Day 2 24 hr

Title	Measurements
	OG000-0.018± 0.019 OG0010.093± 0.023 OG0020.184± 0.025 OG003

Day 2 36 hr

Title	Measurements
	OG000-0.020± 0.020 OG0010.040± 0.024 OG0020.104± 0.022 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0001.475± 0.059 OG0011.506± 0.065 OG0021.472± 0.062 OG0031.483± 0.063 OG0041.493± 0.065 OG0051.488± 0.064

Day 1 0.08 hr

Title	Measurements
	OG0001.474± 0.060 OG0011.549± 0.064 OG0021.561± 0.064 OG003

Day 1 0.25 hr

Title	Measurements
	OG0001.482± 0.059 OG0011.592± 0.064 OG0021.627± 0.063 OG003

Day 1 0.5 hr

Title	Measurements
	OG0001.494± 0.060 OG0011.640± 0.064 OG0021.658± 0.063 OG003

Day 1 1 hr

Title	Measurements
	OG0001.485± 0.061 OG0011.657± 0.066 OG0021.688± 0.065 OG003

Day 1 2 hr

Title	Measurements
	OG0001.477± 0.061 OG0011.671± 0.067 OG0021.701± 0.067 OG003

Day 1 3 hr

Title	Measurements
	OG0001.494± 0.061 OG0011.707± 0.069 OG0021.758± 0.068 OG003

Day 1 4 hr

Title	Measurements
	OG0001.491± 0.061 OG0011.730± 0.068 OG0021.780± 0.068 OG003

Day 1 6 hr

Title	Measurements
	OG0001.477± 0.062 OG0011.721± 0.070 OG0021.748± 0.070 OG003

Day 1 8 hr

Title	Measurements
	OG0001.490± 0.062 OG0011.674± 0.070 OG0021.732± 0.070 OG003

Day 1 12 hr

Title	Measurements
	OG0001.428± 0.061 OG0011.629± 0.069 OG0021.660± 0.066 OG003

Day 1 14 hr

Title	Measurements
	OG0001.409± 0.061 OG0011.605± 0.068 OG0021.646± 0.068 OG003

Day 2 23 hr

Title	Measurements
	OG0001.411± 0.061 OG0011.542± 0.068 OG0021.606± 0.070 OG003

Day 2 24 hr

Title	Measurements
	OG0001.464± 0.062 OG0011.599± 0.070 OG0021.655± 0.071 OG003

Day 2 36 hr

Title	Measurements
	OG0001.464± 0.064 OG0011.564± 0.068 OG0021.575± 0.068 OG003

Title

Denominators

Categories

Change from baseline in FVC AUC0-12

Title	Measurements
	OG0000.026± 0.026 OG0010.253± 0.037 OG0020.297± 0.036 OG0030.306± 0.034 OG0040.372± 0.037 OG0050.237± 0.033

Change from baseline in FVC AUC0-24

Title	Measurements
	OG000-0.034± 0.027 OG0010.170± 0.036 OG0020.253± 0.039 OG003

Change from baseline in FVC AUC12-24

Title	Measurements
	OG000-0.096± 0.031 OG0010.089± 0.039 OG0020.208± 0.045 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.165± 0.101 OG0013.195± 0.104 OG0023.137± 0.102 OG0033.153± 0.094 OG0043.212± 0.108 OG0053.190± 0.106

Day 1 0.08 hr

Title	Measurements
	OG0000.048± 0.026 OG0010.098± 0.027 OG0020.166± 0.034 OG003

Day 1 0.25 hr

Title	Measurements
	OG0000.004± 0.027 OG0010.140± 0.033 OG0020.193± 0.037 OG003

Day 1 0.5 hr

Title	Measurements
	OG0000.127± 0.085 OG0010.191± 0.035 OG0020.232± 0.037 OG003

Day 1 1 hr

Title	Measurements
	OG0000.052± 0.029 OG0010.242± 0.041 OG0020.263± 0.043 OG003

Day 1 2 hr

Title	Measurements
	OG0000.036± 0.035 OG0010.224± 0.041 OG0020.0269± 0.040 OG003

Day 1 3 hr

Title	Measurements
	OG0000.020± 0.026 OG0010.248± 0.044 OG0020.338± 0.041 OG003

Day 1 4 hr

Title	Measurements
	OG0000.016± 0.030 OG0010.297± 0.042 OG0020.379± 0.039 OG003

Day 1 6 hr

Title	Measurements
	OG0000.036± 0.034 OG0010.340± 0.048 OG0020.327± 0.044 OG003

Day 1 8 hr

Title	Measurements
	OG0000.048± 0.037 OG0010.263± 0.045 OG0020.309± 0.044 OG003

Day 1 12 hr

Title	Measurements
	OG000-0.035± 0.038 OG0010.198± 0.048 OG0020.259± 0.046 OG003

Day 1 14 hr

Title	Measurements
	OG000-0.110± 0.043 OG0010.107± 0.047 OG0020.236± 0.050 OG003

Day 2 23 hr

Title	Measurements
	OG000-0.093± 0.037 OG0010.039± 0.042 OG0020.153± 0.050 OG003

Day 2 24 hr

Title	Measurements
	OG000-0.076± 0.035 OG0010.090± 0.039 OG0020.186± 0.038 OG003

Day 2 36 hr

Title	Measurements
	OG000-0.023± 0.037 OG0010.063± 0.040 OG0020.114± 0.045 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0003.165± 0.101 OG0013.195± 0.104 OG0023.137± 0.102 OG0033.153± 0.094 OG0043.212± 0.108 OG0053.190± 0.106

Day 1 0.08 hr

Title	Measurements
	OG0003.205± 0.106 OG0013.293± 0.112 OG0023.318± 0.105 OG003

Day 1 0.25 hr

Title	Measurements
	OG0003.169± 0.098 OG0013.335± 0.109 OG0023.329± 0.102 OG003

Day 1 0.5 hr

Title	Measurements
	OG0003.292± 0.126 OG0013.399± 0.110 OG0023.368± 0.105 OG003

Day 1 1 hr

Title	Measurements
	OG0003.217± 0.104 OG0013.436± 0.110 OG0023.400± 0.107 OG003

Day 1 2 hr

Title	Measurements
	OG0003.201± 0.101 OG0013.418± 0.111 OG0023.406± 0.107 OG003

Day 1 3 hr

Title	Measurements
	OG0003.185± 0.099 OG0013.443± 0.109 OG0023.475± 0.106 OG003

Day 1 4 hr

Title	Measurements
	OG0003.181± 0.101 OG0013.492± 0.108 OG0023.516± 0.103 OG003

Day 1 6 hr

Title	Measurements
	OG0003.220± 0.097 OG0013.535± 0.118 OG0023.464± 0.109 OG003

Day 1 8 hr

Title	Measurements
	OG0003.232± 0.103 OG0013.458± 0.114 OG0023.445± 0.110 OG003

Day 1 12 hr

Title	Measurements
	OG0003.130± 0.105 OG0013.406± 0.118 OG0023.396± 0.108 OG003

Day 1 14 hr

Title	Measurements
	OG0003.055± 0.107 OG0013.302± 0.112 OG0023.359± 0.111 OG003

Day 2 23 hr

Title	Measurements
	OG0003.075± 0.108 OG0013.233± 0.111 OG0023.290± 0.107 OG003

Day 2 24 hr

Title	Measurements
	OG0003.095± 0.103 OG0013.284± 0.109 OG0023.323± 0.104 OG003

Day 2 36 hr

Title	Measurements
	OG0003.145± 0.102 OG0013.289± 0.109 OG0023.251± 0.108 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.240± 0.082 OG0012.239± 0.078 OG0022.234± 0.075 OG0032.254± 0.077 OG0042.237± 0.077 OG0052.246± 0.076

Day 1 4 hr

Title	Measurements
	OG0000.004± 0.037 OG0010.260± 0.039 OG0020.239± 0.040 OG003

Day 2 24 hr

Title	Measurements
	OG000-0.047± 0.040 OG0010.110± 0.037 OG0020.157± 0.037 OG003

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0002.240± 0.082 OG0012.239± 0.078 OG0022.234± 0.075 OG0032.254± 0.077 OG0042.237± 0.077 OG0052.246± 0.076

Day 1 4 hr

Title	Measurements
	OG0002.279± 0.076 OG0012.504± 0.081 OG0022.473± 0.083 OG003

Day 2 24 hr

Title	Measurements
	OG0002.203± 0.074 OG0012.374± 0.082 OG0022.398± 0.085 OG003