Safety and Efficacy of Indacaterol Once Daily Versus Salm... | NCT00821093

NCT00821093

ID	Type	Description	Link
2008-005146-23	EudraCT Number

Status 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 150 µg	Experimental	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) 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 150 µg Drug: Placebo to salmeterol
Salmeterol 50 µg	Active Comparator	Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 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: Salmeterol 50 µg Drug: Placebo to indacaterol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indacaterol 150 µg	Drug	Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).	Indacaterol 150 µg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84)	FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; 1, 2, 3, 4, and 8 hours; 11 hours 10 minutes and 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.	From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)

Secondary 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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigator Site		Anniston	Alabama	36207-5710	United States
Novartis Investigator Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21367594	Derived	Korn S, Kerwin E, Atis S, Amos C, Owen R, Lassen C; INSIST study group. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study. Respir Med. 2011 May;105(5):719-26. doi: 10.1016/j.rmed.2011.02.008. Epub 2011 Mar 1.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Indacaterol 150 μg	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) 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 150 μg	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) 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	Salmeterol 50 μg	Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 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

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Demographic data are based on the safety set of patients.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0001.47± 0.009 OG0011.41± 0.010

Secondary

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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol 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 150 μg	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) 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	Salmeterol 50 μg	Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 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 150 μg	Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) 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.			20	559	0	559
EG001	Salmeterol 50 μg	Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 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.			16	562	0	562

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected559 at risk EG0010 affected562 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Contrast media allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected559 at risk EG0010 affected562 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0011 affected562 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0011 affected562 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Radicular syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0011 affected562 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected559 at risk EG0017 affected562 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected559 at risk EG0012 affected562 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected559 at risk EG0010 affected562 at risk

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004417	Dyspnea

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
D012120	Respiration Disorders
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines