Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
318
1 country
54
Brief Summary
This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 12, 2010
CompletedFirst Posted
Study publicly available on registry
February 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedResults Posted
Study results publicly available
August 19, 2011
CompletedAugust 19, 2011
July 1, 2011
5 months
February 12, 2010
July 22, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (1)
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment
after 12 weeks
Study Arms (2)
Indacaterol 75 µg
EXPERIMENTALIndacaterol 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator FEV1 \<80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
You may not qualify if:
- Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (54)
Novartis Investigative Site
Anniston, Alabama, 36207-5710, United States
Novartis Investigative Site
Jasper, Alabama, 35501, United States
Novartis Investigator Site
Glendale, Arizona, 85306, United States
Novartis Investigator Site
Phoenix, Arizona, 85006, United States
Novartis Investigator Site
Fullerton, California, 92835, United States
Novartis Investigator Site
Los Angeles, California, 90048, United States
Novartis Investigator Site
Los Angeles, California, 90095, United States
Novartis Investigator Site
Riverside, California, 92506, United States
Novartis Investigative Site
Clearwater, Florida, 33756, United States
Novartis Investigative Site
Clearwater, Florida, 33765, United States
Novartis Investigative Site
Hollywood, Florida, 33021, United States
Novartis Investigative site
Miami, Florida, 33145, United States
Novartis Investigative Site
Tampa, Florida, 33603, United States
Novartis Investigative Site
Winter Park, Florida, 32789, United States
Novartis Investigative Site
Atlanta, Georgia, 30342, United States
Novartis Investigator Site
Normal, Illinois, 61761, United States
Novartis Investigator Site
Iowa City, Iowa, 52242, United States
Novartis Investigative Site
Madisonville, Kentucky, 42431, United States
Novartis Investigator Site
Baton Rouge, Louisiana, 70808, United States
Novartis Investigator Site
Opelousas, Louisiana, 70570, United States
Novartis Investigator Site
Saint Charles, Missouri, 63301, United States
Novartis Investigator Site
St Louis, Missouri, 63141, United States
Novartis Investigator Site
Lincoln, Nebraska, 68510, United States
Novartis Investigator Site
Omaha, Nebraska, 68114, United States
Novartis Investigator Site
Omaha, Nebraska, 68134, United States
Novartis Investigator Site
Henderson, Nevada, 89014, United States
Novartis Investigator Site
Las Vegas, Nevada, 89119, United States
Novartis Investigative Site
Cherry Hill, New Jersey, 08003, United States
Novartis Investigator Site
Albuquerque, New Mexico, 87108, United States
Novartis Investigative Site
Charlotte, North Carolina, 28207, United States
Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
Novartis Investigative Site
Shelby, North Carolina, 28152, United States
Novartis Investigative Site
Canton, Ohio, 44718, United States
Novartis Investigator Site
Cincinnati, Ohio, 45242, United States
Novartis Investigative Site
Columbus, Ohio, 43213, United States
Novartis Investigative Site
Columbus, Ohio, 43215, United States
Novartis Investigator Site
Marion, Ohio, 43302, United States
Novartis Investigator Site
Eugene, Oregon, 97404, United States
Novartis Investigator Site
Medford, Oregon, 97504, United States
Novartis Investigative Site
Cumberland, Rhode Island, 02864, United States
Novartis Investigative Site
Pawtucket, Rhode Island, 02860, United States
Novartis Investigative Site
Charleston, South Carolina, 29407, United States
Novartis Investigative Site
Charleston, South Carolina, 29412, United States
Novartis Investigative Site
Easley, South Carolina, 29640, United States
Novartis Investigative site
Greenville, South Carolina, 29615, United States
Novartis Investigative Site
North Charleston, South Carolina, 29406, United States
Novartis Investigative Site
Spartanburg, South Carolina, 29303, United States
Novartis Investigative Site
Union, South Carolina, 29379, United States
Novartis Investigator Site
Arlington, Texas, 76012, United States
Novartis Investigator Site
Dickinson, Texas, 77539, United States
Novartis Investigator Site
El Paso, Texas, 79903, United States
Novartis Investigator Site
McKinney, Texas, 75069, United States
Novartis Investigative Site
South Burlington, Vermont, 05403, United States
Novartis Investigative Site
Richmond, Virginia, 23229, United States
Related Publications (2)
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.
PMID: 23020650DERIVEDKerwin 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.
PMID: 22177371DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 12, 2010
First Posted
February 15, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2010
Last Updated
August 19, 2011
Results First Posted
August 19, 2011
Record last verified: 2011-07