12-week Efficacy of Indacaterol | NCT01072448

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indacaterol 75 μg	Experimental	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol 75 μg
Placebo to indacaterol	Placebo Comparator	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.	Drug: Placebo to indacaterol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol 75 μg	Drug	Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.	Indacaterol 75 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.	24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

Secondary Outcomes

Measure	Description	Time Frame
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)	An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Peoria	Arizona	85381	United States
Novartis Investigator Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23020650	Derived	Gotfried MH, Kerwin EM, Lawrence D, Lassen C, Kramer B. Efficacy of indacaterol 75 mug once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies. COPD. 2012 Dec;9(6):629-36. doi: 10.3109/15412555.2012.729623. Epub 2012 Sep 28.
22177371	Derived	Kerwin EM, Gotfried MH, Lawrence D, Lassen C, Kramer B. Efficacy and tolerability of indacaterol 75 mug once daily in patients aged >/=40 years with chronic obstructive pulmonary disease: results from 2 double-blind, placebo-controlled 12-week studies. Clin Ther. 2011 Dec;33(12):1974-84. doi: 10.1016/j.clinthera.2011.11.009.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Indacaterol 75 μg	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Indacaterol 75 μg	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG001	Placebo to Indacaterol	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
BG002	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) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)

FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Liters

24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

ID	Title	Description
OG000	Indacaterol 75 μg	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
OG001	Placebo to Indacaterol	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Units	Counts
Participants	OG000149 OG001148

Title

Denominators

Categories

Title	Measurements
	OG0001.38± 0.013 OG0011.26± 0.013

Secondary

Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)

An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.

Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

Units on a scale

End of the study (Week 12, Day 84)

ID	Title	Description
OG000	Indacaterol 75 μg	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
OG001	Placebo to Indacaterol	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Indacaterol 75 μg	Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.			4	163	29	163
EG001	Placebo to Indacaterol	Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.			9	160	23	160

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected163 at risk EG0010 affected160 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected163 at risk EG0010 affected160 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0012 affected160 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected163 at risk EG0010 affected160 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected163 at risk EG0014 affected160 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected163 at risk EG0011 affected160 at risk

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

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected163 at risk EG0012 affected160 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected163 at risk EG0016 affected160 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00014 affected163 at risk EG00115 affected160 at risk