Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control - Full Text View

Purpose

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Indacaterol 150 μg Drug: Salmeterol 50 μg Drug: Placebo to Indacaterol Drug: Placebo to Salmeterol	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Salmeterol Salmeterol xinafoate Indacaterol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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 salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.

Secondary Outcome Measures:

St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.

Enrollment:	1002
Study Start Date:	November 2007
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Indacaterol 150 μg Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Indacaterol 150 μg Indacaterol 150 μg once daily (o.d) inhaled Drug: Placebo to Salmeterol Placebo to salmeterol delivered via a proprietary dry powder inhaler
Placebo Comparator: Placebo Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Placebo to Indacaterol Placebo to Indacaterol inhaled via SDDPI. Drug: Placebo to Salmeterol Placebo to salmeterol delivered via a proprietary dry powder inhaler
Active Comparator: Salmeterol 50 μg Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.	Drug: Salmeterol 50 μg Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler Drug: Placebo to Indacaterol Placebo to Indacaterol inhaled via SDDPI.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

Smoking history of at least 20 pack years
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
Concomitant pulmonary disease
Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
History of reactions to sympathomimetic amines or inhaled medication
Inability to use the dry powder devices or perform spirometry
Irregular day/night, wake/sleep cycles, e.g. shift workers
Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567996

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Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Pharma AG

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. Epub 2011 Mar 11.

Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. Epub 2011 Jan 11.

Responsible Party:	External affairs, novartis
ClinicalTrials.gov Identifier:	NCT00567996 History of Changes
Other Study ID Numbers:	CQAB149B2336
Study First Received:	December 4, 2007
Results First Received:	July 22, 2011
Last Updated:	July 22, 2011
Health Authority:	Brazil: Ministry of Health Canada: Health Canada Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Iceland: Icelandic Medicines Control Agency India: Ministry of Health Italy: Ministry of Health Norway: Norwegian Medicines Agency Peru: Ministry of Health Russia: Ministry of Health of the Russian Federation Slovakia: State Institute for Drug Control Taiwan: Department of Health Finland: Finnish Medicines Agency

Keywords provided by Novartis:

Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013