MedDataX Logo

Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01089127

Last Updated: 2011-08-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)

NCT00821093

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

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

NCT00567996

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00615030

Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED PHASE3

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00624286

Chronic Obstructive Pulmonary Disease
COMPLETED PHASE3

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00463567

Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive
COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Indacaterol 18.75 μg

Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Indacaterol 37.5 μg

Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Indacaterol 75 μg

Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Indacaterol 150 μg

Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type EXPERIMENTAL

Indacaterol

Intervention Type DRUG

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Salmeterol 50 μg

Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type ACTIVE_COMPARATOR

Salmeterol 50 μg

Intervention Type DRUG

Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo

Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.

Group Type PLACEBO_COMPARATOR

Placebo to indacaterol

Intervention Type DRUG

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to salmeterol

Intervention Type DRUG

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indacaterol

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Salmeterol 50 μg

Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Intervention Type DRUG

Placebo to indacaterol

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Intervention Type DRUG

Placebo to salmeterol

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and:

1. Smoking history of at least 10 pack-years
2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Novartis Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigator Site

Florence, Alabama, United States

Site Status

Novartis Investigator Site

Jasper, Alabama, United States

Site Status

Novartis Investigator Site

Phoenix, Arizona, United States

Site Status

Novartis Investigator Site

Searcy, Arkansas, United States

Site Status

Novartis Investigator Site

Fullerton, California, United States

Site Status

Novartis Investigative Site

Rancho Mirage, California, United States

Site Status

Novartis Investigator Site

Riverside, California, United States

Site Status

Novartis Investigator Site

San Diego, California, United States

Site Status

Novartis Investigator Site

Stockton, California, United States

Site Status

Novartis Investigator Site

Temecula, California, United States

Site Status

Novartis Investigator Site

Walnut Creek, California, United States

Site Status

Novartis Investigator Site

Wheat Ridge, Colorado, United States

Site Status

Novartis Investigative Site

Glastonbury, Connecticut, United States

Site Status

Novartis Investigative Site

Stamford, Connecticut, United States

Site Status

Novartis Investigator Site

Clearwater, Florida, United States

Site Status

Novartis Investigator Site

DeFuniak Springs, Florida, United States

Site Status

Novartis Investigative Site

Hollywood, Florida, United States

Site Status

Novartis Investigator Site

Miami, Florida, United States

Site Status

Novartis Investigative Site

Pensacola, Florida, United States

Site Status

Novartis Investigative Site

Pensacola, Florida, United States

Site Status

Novartis Investigative Site

Tamarac, Florida, United States

Site Status

Novartis Investigator Site

Tampa, Florida, United States

Site Status

Novartis Investigator Site

O'Fallon, Illinois, United States

Site Status

Novartis Investigator Site

Florence, Kentucky, United States

Site Status

Novartis Investigator Site

Madisonville, Kentucky, United States

Site Status

Novartis Investigator Site

Opelousas, Louisiana, United States

Site Status

Novartis Investigative Site

Columbia, Maryland, United States

Site Status

Novartis Investigator Site

Edina, Minnesota, United States

Site Status

Novartis Investigator Site

Fridley, Minnesota, United States

Site Status

Novartis Investigator Site

Minneapolis, Minnesota, United States

Site Status

Novartis Investigator Site

Ozark, Missouri, United States

Site Status

Novartis Investigator Site

St Louis, Missouri, United States

Site Status

Novartis Investigator Site

Bellevue, Nebraska, United States

Site Status

Novartis Investigator Site

Lincoln, Nebraska, United States

Site Status

Novartis Investigator Site

Omaha, Nebraska, United States

Site Status

Novartis Investigator Site

Henderson, Nevada, United States

Site Status

Novartis Investigator Site

Las Vegas, Nevada, United States

Site Status

Novartis Investigator Site

Las Vegas, Nevada, United States

Site Status

Novartis Investigator Site

Lebanon, New Hampshire, United States

Site Status

Novartis Investigative Site

Cherry Hill, New Jersey, United States

Site Status

Novartis Investigative Site

Bayside, New York, United States

Site Status

Novartis Investigative Site

Great Neck, New York, United States

Site Status

Novartis Investigative Site

Lake Success, New York, United States

Site Status

Novartis Investigative Site

Larchmont, New York, United States

Site Status

Novartis Investigative Site

Charlotte, North Carolina, United States

Site Status

Novartis Investigative Site

Shelby, North Carolina, United States

Site Status

Novartis Investigator Site

Cadiz, Ohio, United States

Site Status

Novartis Investigator Site

Canton, Ohio, United States

Site Status

Novartis Investigator Site

Columbus, Ohio, United States

Site Status

Novartis Investigator Site

Toledo, Ohio, United States

Site Status

Novartis Investigative Site

Eugene, Oregon, United States

Site Status

Novartis Investigator Site

Medford, Oregon, United States

Site Status

Novartis Investigative Site

Phoenixville, Pennsylvania, United States

Site Status

Novartis Investigative Site

Pittsburgh, Pennsylvania, United States

Site Status

Novartis Investigative site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Charleston, South Carolina, United States

Site Status

Novartis Investigative Site

Easley, South Carolina, United States

Site Status

Novartis Investigative Site

Greenville, South Carolina, United States

Site Status

Novartis Investigative Site

Spartanburg, South Carolina, United States

Site Status

Novartis Investigative Site

Union, South Carolina, United States

Site Status

Novartis Investigator Site

Cookeville, Tennessee, United States

Site Status

Novartis Investigator Site

Dickinson, Texas, United States

Site Status

Novartis Investigator Site

Fort Worth, Texas, United States

Site Status

Novartis Investigator Site

McKinney, Texas, United States

Site Status

Novartis Investigator Site

Salt Lake City, Utah, United States

Site Status

Novartis Investigative Site

Fredericksburg, Virginia, United States

Site Status

Novartis Investigative site

Newport News, Virginia, United States

Site Status

Novartis Investigative Site

Richmond, Virginia, United States

Site Status

Novartis Investigator Site

Tacoma, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CQAB149B2356

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00677807 COMPLETED PHASE3
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
NCT01068600 COMPLETED PHASE3
12-week Efficacy of Indacaterol
NCT01072448 COMPLETED PHASE3
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
NCT00393458 COMPLETED PHASE3
Indacaterol 75 μg Compared to Placebo, Assessing Time to Patient's Perception of Onset of Effect in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01543828 COMPLETED PHASE4
A Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00622635 COMPLETED PHASE3
Efficacy of Indacaterol 150 µg Versus Formoterol
NCT01377428 WITHDRAWN PHASE4
Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)
NCT00792805 COMPLETED PHASE3
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00794157 COMPLETED PHASE3
Study to Determine the Onset of Action of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00669617 COMPLETED PHASE3
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01604278 COMPLETED PHASE3
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
NCT00846586 COMPLETED PHASE3
Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations
NCT02418468 COMPLETED PHASE4
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT00620022 COMPLETED PHASE3
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00876694 COMPLETED PHASE3
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
NCT00900731 COMPLETED PHASE3
An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD)
NCT00636961 COMPLETED PHASE2
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
NCT00396604 COMPLETED PHASE2/PHASE3
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol
NCT00422552 COMPLETED PHASE1/PHASE2
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
NCT00877383 COMPLETED PHASE3
A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
NCT01712516 COMPLETED PHASE3
Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity
NCT00999908 COMPLETED PHASE3
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
NCT01794780 COMPLETED PHASE4
Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma
NCT00403637 COMPLETED PHASE2/PHASE3
Dose Ranging Study of Indacaterol in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00403845 COMPLETED PHASE2