Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)
INSIST
A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler
2 other identifiers
interventional
1,123
8 countries
144
Brief Summary
This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2009
Shorter than P25 for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 9, 2009
CompletedFirst Posted
Study publicly available on registry
January 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
August 18, 2011
CompletedAugust 18, 2011
July 1, 2011
9 months
January 9, 2009
July 22, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (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)
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Study Arms (2)
Indacaterol 150 µg
EXPERIMENTALPatients 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.
Salmeterol 50 µg
ACTIVE COMPARATORPatients 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.
Interventions
Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).
Placebo to indacaterol was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).
Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).
Eligibility Criteria
You may qualify if:
- Adults aged ≥ 40 years
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) 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 at screening
- Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70% at screening
You may not qualify if:
- Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
- Patients requiring long-term oxygen therapy (\> 15 h a day) for chronic hypoxemia
- 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
- Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
- Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
- Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
- Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (144)
Novartis Investigator Site
Anniston, Alabama, 36207-5710, United States
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Fairhope, Alabama, 36532, United States
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Jasper, Alabama, 35501, United States
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Mobile, Alabama, 36604, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85006, United States
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Buena Park, California, 90620, United States
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Encinitas, California, 92024, United States
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Fullerton, California, 92535, United States
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Rancho Mirage, California, 92270, United States
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Riverside, California, 92506, United States
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San Diego, California, 92120, United States
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Torrance, California, 90505, United States
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Walnut Creek, California, 94598, United States
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Fort Collins, Colorado, 80528, United States
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Wheat Ridge, Colorado, 80033, United States
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Stamford, Connecticut, 06902, United States
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Newark, Delaware, 19713, United States
Novartis Investigative Center
Clearwater, Florida, 33765, United States
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Pensacola, Florida, 32504, United States
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Pensacola, Florida, 32514, United States
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South Miami, Florida, 33143, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33603, United States
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Tampa, Florida, 33613, United States
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Marietta, Georgia, 30060, United States
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Normal, Illinois, 61761, United States
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River Forest, Illinois, 60305, United States
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Skokie, Illinois, 60076, United States
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Olathe, Kansas, 66061, United States
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Wichita, Kansas, 67207, United States
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Madisonville, Kentucky, 42431, United States
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New Orleans, Louisiana, 70115, United States
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Opelousas, Louisiana, 70570, United States
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Baltimore, Maryland, 21236, United States
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Ann Arbor, Michigan, 48106, United States
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Livonia, Michigan, 48152, United States
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Minneapolis, Minnesota, 55407, United States
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Saint Charles, Missouri, 63301-2847, United States
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St Louis, Missouri, 63141, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68134, United States
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Henderson, Nevada, 89014, United States
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Reno, Nevada, 89502, United States
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Cherry Hill, New Jersey, 08003, United States
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Summit, New Jersey, 07901, United States
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Albuquerque, New Mexico, 87108, United States
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Larchmont, New York, 10538, United States
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Charlotte, North Carolina, 28207, United States
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Hickory, North Carolina, 28601, United States
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Raleigh, North Carolina, 27607, United States
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Shelby, North Carolina, 28150, United States
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Cincinnati, Ohio, 45245, United States
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Columbus, Ohio, 42313, United States
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Willoughby Hills, Ohio, 44094, United States
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Tulsa, Oklahoma, 74135-2920, United States
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Eugene, Oregon, 97404, United States
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Medford, Oregon, 97504-8741, United States
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Portland, Oregon, 97213, United States
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Erie, Pennsylvania, 16506, United States
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Charleston, South Carolina, 29412, United States
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Greenville, South Carolina, 29615, United States
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North Charleston, South Carolina, 29406-7108, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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El Paso, Texas, 79903, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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San Antonio, Texas, 78212, United States
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Abingdon, Virginia, 24210, United States
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Richmond, Virginia, 23229, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405-4266, United States
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Milwaukee, Wisconsin, 53209-0996, United States
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Cvikov, Czechia
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Kyjov, Czechia
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Lovosice, Czechia
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Neratovice, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Teplice, Czechia
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Aschaffenburg, Germany
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Augsburg, Germany
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Backnang, Germany
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Berlin, Germany
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Berlin, Germany
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Bielefeld, Germany
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Borstel, Germany
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Dortmund, Germany
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Duisburg, Germany
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Frankfurt, Germany
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Geesthacht, Germany
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Hagen, Germany
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Hamburg, Germany
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Karlsruhe, Germany
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Kiel, Germany
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Leipzig, Germany
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Lübeck, Germany
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Mainz, Germany
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Marburg, Germany
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Neumünster, Germany
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Oschersleben, Germany
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Rüdersdorf, Germany
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Weyhe, Germany
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Wiesloch, Germany
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Witten, Germany
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Budapest, Hungary
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Debrecen, Hungary
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Deszk, Hungary
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Mosonmagyaróvár, Hungary
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Nyíregyháza, Hungary
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Tatabánya, Hungary
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Törökbálint, Hungary
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Chennai, India
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Hyderabad, India
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Jaipur, India
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Mangalore, India
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Panjim, India
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Pune, India
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Trivandrum, India
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Vellore, India
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Bojnice, Slovakia
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Bratislava, Slovakia
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Humenné, Slovakia
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Košice, Slovakia
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Liptovský Hrádok, Slovakia
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Partizánske, Slovakia
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Spišská Nová Ves, Slovakia
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A Coruña, Spain
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Alicante, Spain
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Barcelona, Spain
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Cáceres, Spain
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Córdoba, Spain
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Mérida, Spain
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Ourense, Spain
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Valencia, Spain
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Altunizade, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kartal/Istanbul, Turkey (Türkiye)
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Kinikli / Denizli, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
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Yenisehir/Izmir, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 21367594DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceticals
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
January 9, 2009
First Posted
January 13, 2009
Study Start
January 1, 2009
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 18, 2011
Results First Posted
August 18, 2011
Record last verified: 2011-07