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Chronic Obstructive Pulmonary Disease (COPD)Phase 3INSISTNCT00821093

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

A Phase 3 study testing Indacaterol 150 µg and Salmeterol 50 µg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 144 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Indacaterol 150 µg and Salmeterol 50 µg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,123 participants
Where
144 sitesin 8 countries
Study dates
Jan 2009to Oct 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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
  • Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

144 sites in 8 countries.

144 sites in 8 countries

United States74 sites

  • Novartis Investigative Site

    Abingdon, Virginia, 24210

  • Novartis Investigator Site

    Albuquerque, New Mexico, 87108

  • Novartis Investigator Site

    Ann Arbor, Michigan, 48106

  • Novartis Investigator Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Baltimore, Maryland, 21236

  • Novartis Investigator Site

    Buena Park, California, 90620

  • Novartis Investigative Site

    Charleston, South Carolina, 29412

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Cherry Hill, New Jersey, 08003

  • Novartis Investigator Site

    Cincinnati, Ohio, 45245

  • Novartis Investigative Center

    Clearwater, Florida, 33765

  • Novartis Investigator Site

    Columbus, Ohio, 42313

  • Novartis Investigator Site

    El Paso, Texas, 79903

  • Novartis Investigator Site

    Encinitas, California, 92024

  • Novartis Investigative Site

    Erie, Pennsylvania, 16506

  • Novartis Investigator Site

    Eugene, Oregon, 97404

  • Novartis Investigator Site

    Fairhope, Alabama, 36532

  • Novartis Investigator Site

    Fort Collins, Colorado, 80528

  • Novartis Investigator Site

    Fort Worth, Texas, 76104

  • Novartis Investigator Site

    Fullerton, California, 92535

  • Novartis Investigator Site

    Glendale, Arizona, 85306

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigator Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Hickory, North Carolina, 28601

  • Novartis Investigator Site

    Houston, Texas, 77024

  • Novartis Investigator Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Larchmont, New York, 10538

  • Novartis Investigator Site

    Lincoln, Nebraska, 68510

  • Novartis Investigator Site

    Livonia, Michigan, 48152

  • Novartis Investigator Site

    Madisonville, Kentucky, 42431

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigator Site

    Medford, Oregon, 97504-8741

  • Novartis Investigator Site

    Milwaukee, Wisconsin, 53209-0996

  • Novartis Investigator Site

    Minneapolis, Minnesota, 55407

  • Novartis Investigator Site

    Mobile, Alabama, 36604

  • Novartis Investigator Site

    New Orleans, Louisiana, 70115

  • Novartis Investigative Site

    Newark, Delaware, 19713

  • Novartis Investigator Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    North Charleston, South Carolina, 29406-7108

  • Novartis Investigator Site

    Olathe, Kansas, 66061

  • Novartis Investigator Site

    Omaha, Nebraska, 68134

  • Novartis Investigator Site

    Opelousas, Louisiana, 70570

  • Novartis Investigative Site

    Pensacola, Florida, 32504

  • Novartis Investigative Site

    Pensacola, Florida, 32514

  • Novartis Investigator Site

    Phoenix, Arizona, 85006

  • Novartis Investigator Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigator Site

    Rancho Mirage, California, 92270

  • Novartis Investigative Site

    Reno, Nevada, 89502

  • Novartis Investigative Site

    Richmond, Virginia, 23229

  • Novartis Investigator Site

    River Forest, Illinois, 60305

  • Novartis Investigator Site

    Riverside, California, 92506

  • Novartis Investigator Site

    Saint Charles, Missouri, 63301-2847

  • Novartis Investigator Site

    San Antonio, Texas, 78212

  • Novartis Investigator Site

    San Diego, California, 92120

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigator Site

    Skokie, Illinois, 60076

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative site

    Spartanburg, South Carolina, 29303

  • Novartis Investigator Site

    Spokane, Washington, 99204

  • Novartis Investigator Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Stamford, Connecticut, 06902

  • Novartis Investigative Site

    Summit, New Jersey, 07901

  • Novartis Investigator Site

    Tacoma, Washington, 98405-4266

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Tampa, Florida, 33603

  • Novartis Investigative Site

    Tampa, Florida, 33613

  • Novartis Investigator Site

    Torrance, California, 90505

  • Novartis Investigator Site

    Tulsa, Oklahoma, 74135-2920

  • Novartis Investigative Site

    Union, South Carolina, 29379

  • Novartis Investigator Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Wheat Ridge, Colorado, 80033

  • Novartis Investigator Site

    Wichita, Kansas, 67207

  • Novartis Investigator Site

    Willoughby Hills, Ohio, 44094

Other trials in United States

Germany25 sites

  • Novartis Investigative Site

    Aschaffenburg

  • Novartis Investigative Site

    Augsburg

  • Novartis Investigative Site

    Backnang

  • Novartis Investigative Site

    Berlin

  • Novartis Investigator Site

    Berlin

  • Novartis Investigative Site

    Bielefeld

  • Novartis Investigative Site

    Borstel

  • Novartis Investigative Site

    Dortmund

  • Novartis Investigative Site

    Duisburg

  • Novartis Investigator Site

    Frankfurt

  • Novartis Investigative Site

    Geesthacht

  • Novartis Investigative Site

    Hagen

  • Novartis Investigative Site

    Hamburg

  • Novartis Investigative Site

    Karlsruhe

  • Novartis Investigative Site

    Kiel

  • Novartis Investigator Site

    Leipzig

  • Novartis Investigative Site

    Lübeck

  • Novartis Investigative Site

    Mainz

  • Novartis Investigative Site

    Marburg

  • Novartis Investigative Site

    Neumünster

  • Novartis Investigative SIte

    Oschersleben

  • Novartis Investigative Site

    Rüdersdorf

  • Novartis Investigative Site

    Weyhe

  • Novartis Investigative Site

    Wiesloch

  • Novartis Investgative Site

    Witten

Other trials in Germany

Czechia8 sites

  • Novartis Investigator Site

    Cvikov

  • Novartis Investigator Site

    Kyjov

  • Novartis Investigator Site

    Lovosice

  • Novartis Investigator Site

    Neratovice

  • Novartis Investigator Site

    Ostrava

  • Novartis Investigator Site

    Pardubice

  • Novartis Investigator Site

    Prague

  • Novartis Investigator Site

    Teplice

Other trials in Czechia

India8 sites

  • Novartis Investigator Site

    Chennai

  • Novartis Investigator Site

    Hyderabad

  • Novartis Investigator Site

    Jaipur

  • Novartis Investigator Site

    Mangalore

  • Novartis Investigator Site

    Panjim

  • Novartis Investigator Site

    Pune

  • Novartis Investigator Site

    Trivandrum

  • Novartis Investigator Site

    Vellore

Other trials in India

Spain8 sites

  • Novartis Investigative Site

    A Coruña

  • Novartis Investigator Site

    Alicante

  • Novartis Investigative Site

    Barcelona

  • Novartis Investigative Site

    Cáceres

  • Novartis Investigative Site

    Córdoba

  • Novartis Investigative Site

    Mérida

  • Novartis Investigative Site

    Ourense

  • Novartis Investigative Site

    Valencia

Other trials in Spain

Hungary7 sites

  • Novartis Investigator Site

    Budapest

  • Novartis Investigator Site

    Debrecen

  • Novartis Investigative Site

    Deszk

  • Novartis Investigator Site

    Mosonmagyaróvár

  • Novartis Investigator Site

    Nyíregyháza

  • Novartis Investigator Site

    Tatabánya

  • Novartis Investigator Site

    Törökbálint

Other trials in Hungary

Slovakia7 sites

  • Novartis Investigative Site

    Bojnice

  • Novartis Investigator Site

    Bratislava

  • Novartis Investigative Site

    Humenné

  • Novartis Investigative Site

    Košice

  • Novartis Investigator Site

    Liptovský Hrádok

  • Novartis Investigative Site

    Partizánske

  • Novartis Investigative Site

    Spišská Nová Ves

Other trials in Slovakia

Turkey (Türkiye)7 sites

  • Novartis Investigative Site

    Altunizade

  • Novartis Investigator Site

    Istanbul

  • Novartis Investigator Site

    Izmir

  • Novartis Investigator Site

    Kartal/Istanbul

  • Novartis Investigative Site

    Kinikli / Denizli

  • Novartis Investigative Site

    Mersin

  • Novartis Investigator Site

    Yenisehir/Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Being tested
Indacaterol 150 µg, Salmeterol 50 µg, Placebo to indacaterol, Placebo to salmeterol
Keywords
respiratory, dyspnea, breathlessness, COPD, indacaterol, long-acting β2-agonist
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indacaterol 150 µgDrug

    Indacaterol 150 μg was provided in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

  • Salmeterol 50 µgDrug

    Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).

  • Placebo to indacaterolDrug

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

  • Placebo to salmeterolDrug

    Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]).

Study groups in NCT00821093
Study groupRoleWhat they receive
Indacaterol 150 µgExperimentalPatients 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.
Receives: Drug: Indacaterol 150 µg; Drug: Placebo to salmeterol
Salmeterol 50 µgActive 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.
Receives: Drug: Salmeterol 50 µg; Drug: Placebo to indacaterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)

Secondary outcomes (1)

  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 and FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening as covariates.

    Measured: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821093
Sponsor's protocol ID
CQAB149B2349
Other IDs
2008-005146-23, 2008
Acronym
INSIST
Status last verified
Jul 2011
First submitted
9 Jan 2009
Last updated
18 Aug 2011

Publications

  • 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.

    PubMed 21367594

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 µg and Salmeterol 50 µg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 144 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Germany, Czechia, India, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2011.

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INSIST Clinical Trial NCT00821093 | AzTrials