Comparison of Efficacy of Indacaterol Versus Placebo Over... | NCT01068600

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Indacaterol 75 µg	Experimental	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.	Drug: Indacaterol
Placebo	Placebo Comparator	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.	Drug: Placebo to indacaterol

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol	Drug	Once daily via single-dose dry powder inhaler (SDDPI)	Indacaterol 75 µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment	Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.	after 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment	TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Anniston	Alabama	36207-5710	United States
Novartis Investigative 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	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
BG001	Placebo	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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) After 12 Weeks of Treatment

Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

Full Analysis Set included all randomized participants who received at least one dose of study drug. The endpoint was analyzed only for those participants who had data for this outcome measure. Missing data was imputed using last observation carried forward.

Posted

Least Squares Mean

Standard Error

Liters

after 12 weeks

ID	Title	Description
OG000	Indacaterol 75 µg	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
OG001	Placebo	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.

Units	Counts
Participants	OG000145 OG001150

Title

Denominators

Categories

Title	Measurements
	OG0001.49± 0.016 OG0011.35± 0.015

Secondary

Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment

TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

Full Analysis Set included all randomized participants who received at least one dose of study medication. If data were missing or insufficient for any one of the domains a focal score was not calculated. Missing focal scores after week 4 were imputed using last observation carried forward.

Posted

Least Squares Mean

Standard Error

Score on a scale

after 12 weeks

ID	Title	Description
OG000	Indacaterol 75 µg	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
OG001	Placebo	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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	Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.			4	159	58	159
EG001	Placebo	Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.			4	159	46	159

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Splenic infarction	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected159 at risk
Visual impairment	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected159 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk
Limb crushing injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected159 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0011 affected159 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0010 affected159 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Supraventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Ear pain	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0013 affected159 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0011 affected159 at risk
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected159 at risk EG0012 affected159 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected159 at risk EG0013 affected159 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0012 affected159 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0016 affected159 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected159 at risk EG0016 affected159 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected159 at risk EG0012 affected159 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0014 affected159 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0012 affected159 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0013 affected159 at risk
C-reactive protein increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0012 affected159 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected159 at risk EG0012 affected159 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected159 at risk EG0010 affected159 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected159 at risk EG0012 affected159 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00013 affected159 at risk EG00113 affected159 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00015 affected159 at risk EG0015 affected159 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected159 at risk EG0012 affected159 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected159 at risk EG0010 affected159 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected159 at risk EG0012 affected159 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0004 affected159 at risk EG0012 affected159 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