12-week Efficacy of Indacaterol
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
323
1 country
62
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
Started Jan 2010
Shorter than P25 for phase_3 chronic-obstructive-pulmonary-disease
62 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 19, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 19, 2011
CompletedAugust 19, 2011
July 1, 2011
6 months
February 19, 2010
July 22, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Secondary Outcomes (1)
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
End of the study (Week 12, Day 84)
Study Arms (2)
Indacaterol 75 μg
EXPERIMENTALPatients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM 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.
Placebo to indacaterol
PLACEBO COMPARATORPatients inhaled placebo to indacaterol once daily in the morning between 8:00 AM 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.
Interventions
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Eligibility Criteria
You may qualify if:
- 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:
- Smoking history of at least 10 pack-years
- Post-bronchodilator forced expiratory volume in 1 second (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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (62)
Novartis Investigator Site
Peoria, Arizona, 85381, United States
Novartis Investigator Site
Pine Bluff, Arkansas, 71603, United States
Novartis Investigator Site
Buena Park, California, 90620, United States
Novartis Investigator Site
Encinitas, California, 92024, United States
Novartis Investigator Site
Fountain Valley, California, 92708, United States
Novartis Investigator Site
Los Angeles, California, 90015, United States
Novartis Investigator Site
San Diego, California, 92103, United States
Novartis Investigator Site
San Diego, California, 92120, United States
Novartis Investigator Site
Temecula, California, 92591, United States
Novartis Investigator Site
Torrance, California, 90505, United States
Novartis Investigator Site
Walnut Creek, California, 94598, United States
Novartis Investigator Site
Wheat Ridge, Colorado, 80033, United States
Novartis Investigative Site
Port Orange, Florida, 32127, United States
Novartis Investigative Site
Sarasota, Florida, 34233, United States
Novartis Investigative Site
Tamarac, Florida, 33321, United States
Novartis Investigator Site
Couer D'Alene, Idaho, 83814, United States
Novartis Investigator Site
Champaign, Illinois, 61820, United States
Novartis Investigator Site
Downers Grove, Illinois, 60515, United States
Novartis Investigative Site
River Forest, Illinois, 60305, United States
Novartis Investigator Site
Skokie, Illinois, 60076, United States
Novartis Investigator Site
Springfield, Illinois, 62703, United States
Novartis Investigative site
Lexington, Kentucky, 40504, United States
Novartis Investigator Site
Covington, Louisiana, 70433, United States
Novartis Investigator Site
Metaire, Louisiana, 70002, United States
Novartis Investigative Site
Bangor, Maine, 04401, United States
Novartis Investigative Site
Columbia, Maryland, 21044, United States
Novartis Investigative Site
Clarkston, Michigan, 48346, United States
Novartis Investigative Site
Flint, Michigan, 48532, United States
Novartis Investigative Site
Livonia, Michigan, 48152, United States
Novartis Investigative Site
Edina, Minnesota, 55435, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55402, United States
Novartis Investigative Site
Plymouth, Minnesota, 55441, United States
Novartis Investigator Site
Florissant, Missouri, 63033, United States
Novartis Investigator Site
Ozark, Missouri, 65721, United States
Novartis Investigator Site
St Louis, Missouri, 63117, United States
Novartis Investigative Site
Missoula, Montana, 59808, United States
Novartis Investigator Site
Bellevue, Nebraska, 68123, United States
Novartis Investigator Site
Lincoln, Nebraska, 68516, United States
Novartis Investigator Site
Omaha, Nebraska, 68134, United States
Novartis Investigator Site
Henderson, Nevada, 89014, United States
Novartis Investigator Site
Pahrump, Nevada, 89048, United States
Novartis Investigative Site
New Brunswick, New Jersey, 08902, United States
Novartis Investigative Site
Ocean City, New Jersey, 07712, United States
Novartis Investigative Site
Rochester, New York, 14618, United States
Novartis Investigative Site
Charlotte, North Carolina, 28209, United States
Novartis Investigative Site
Salisbury, North Carolina, 28144, United States
Novartis Investigative Site
Cincinnati, Ohio, 45231, United States
Novartis Investigator Site
Medford, Oregon, 97504, United States
Novartis Investigative Site
Beaver, Pennsylvania, 15009, United States
Novartis Investigative Site
Erie, Pennsylvania, 16506, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15221, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243, United States
Novartis Investigative Site
Gaffney, South Carolina, 29340, United States
Novartis Investigative site
Greer, South Carolina, 29651, United States
Novartis Investigative Site
Seneca, South Carolina, 29678, United States
Novartis Investigative Site
Johnson City, Tennessee, 37601, United States
Novartis Investigator Site
Corsicana, Texas, 75110, United States
Novartis Investigator Site
Fort Worth, Texas, 76109, United States
Novartis Investigator Site
Salt Lake City, Utah, 84107, United States
Novartis Investigator Site
Abingdon, Virginia, 24210, United States
Novartis Investigative Site
Newport News, Virginia, 23606, United States
Novartis Investigator Site
Tacoma, Washington, 98405, 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 19, 2010
First Posted
February 22, 2010
Study Start
January 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
August 19, 2011
Results First Posted
August 19, 2011
Record last verified: 2011-07