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Chronic Obstructive Pulmonary Disease (COPD)Phase 3INTRUST1NCT00846586

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 137 sites in 12 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 assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD) Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Indacaterol 150 μg and Tiotropium 18 μg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,134 participants
Where
137 sitesin 12 countries
Study dates
Mar 2009to Mar 2010
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

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:
  • Smoking history of at least 10 pack-years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

Who cannot join

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
  • Patients with a body mass index less than 15 or more than 40 kg/m^2
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
Show all 9Show fewer
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions
  • Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

137 sites in 12 countries.

137 sites in 12 countries

United States61 sites

  • Novartis Investigator Site

    Asbury Park, New Jersey, 07712

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigator Site

    Bethlehem, Pennsylvania, 18020

  • Novartis Investigator Site

    Birmingham, Alabama, 32509

  • Novartis Investigator Site

    Boys Town, Nebraska, 68010

  • Novartis Investigator Site

    Brockton, Massachusetts, 02301

  • Novartis Investigator Site

    Clarkston, Michigan, 48346

  • Novartis Investigative Site

    Clearwater, Florida, 33756

  • Novartis Investigator Site

    Columbia, Maryland, 21044

  • Novartis Investigator Site

    Conyers, Georgia, 30094

  • Novartis Investigative Site

    Cumberland, Rhode Island, 02864

  • Novartis Investigator Site

    Detroit, Michigan, 48202

  • Novartis Investigator Site

    El Paso, Texas, 79903

  • Novartis Investigator Site

    Fort Walton Beach, Florida, 32547

  • Novartis Investigator Site

    Fountain Valley, California, 92708

  • Novartis Investigator Site

    Greenville, South Carolina, 29615

  • Novartis Investigative Site

    Hartford, Connecticut, 06105-1208

  • Novartis Investigative Site

    Houston, Texas, 77024

  • Novartis Investigative Site

    Houston, Texas, 77079

  • Novartis Investigative Site

    Iowa City, Iowa, 52240

  • Novartis Investigative Site

    Kansas City, Kansas, 66160

  • Novartis Investigator Site

    Knoxville, Tennessee, 37919

  • Novartis Investigator Site

    Lafayette, Louisiana, 70503

  • Novartis Investigative Site

    Las Vegas, Nevada, 89119

  • Novartis Investigator Site

    Lebanon, New Hampshire, 03756

  • Novartis Investigative Site

    Lenexa, Kansas, 66215

  • Novartis Investigator Site

    Long Beach, California, 90822

  • Novartis Investigative Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Medford, Oregon, 97504

  • Novartis Investigator Site

    Metaire, Louisiana, 70002

  • Novartis Investigative Site

    Miami, Florida, 33136

  • Novartis Investigative Site

    Miami, Florida, 331577

  • Novartis Investigator Site

    Missoula, Montana, 59808

  • Novartis Investigator Site

    Mobile, Alabama, 36608

  • Novartis Investigator Site

    Mooresville, North Carolina, 28117

  • Novartis Investigative Site

    Naranja, Florida, 33032

  • Novartis Investigator Site

    National City, California, 91950

  • Novartis Investigative Center

    New Braunfels, Texas, 78130-6113

  • Novartis Investigator Site

    New Orleans, Louisiana, 70119

  • Novartis Investigator Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative site

    Omaha, Nebraska, 68134

  • Novartis Investigator Site

    Palmdale, California, 93551

  • Novartis Investigator Site

    Pensacola, Florida, 32514

  • Novartis Investigator Site

    Pine Bluff, Arkansas, 71603

  • Novartis Investigative Site

    Richmond, Virginia, 23225

  • Novartis Investigator Site

    Richmond, Virginia, 23249

  • Novartis Investigative Site

    Rochester, New York, 14618

  • Novartis Investigative Site

    Saint Charles, Missouri, 63301

  • Novartis Investigator Site

    Sarasota, Florida, 34233

  • Novartis Investigative Site

    Scottsdale, Arizona, 85258

  • Novartis Investigator Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29303

  • Novartis Investigative Site

    Stockton, California, 95207

  • Novartis Investigator Site

    Temecula, California, 92591

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Tucson, Arizona, 85712

  • Novartis Investigative Site

    Tucson, Arizona, 85723

  • Novartis Investigator Site

    Tulsa, Oklahoma, 74135-2920

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany21 sites

  • Novartis Investigator Site

    Berlin

  • Novartis Investigator Site

    Cottbus

  • Novartis Investigator Site

    Donaustauf

  • Novartis Investigator Site

    Dortmund

  • Novartis Investigator Site

    Erfurt

  • Novartis Investigator Site

    Frankfurt

  • Novartis Investigator Site

    Gelnhausen

  • Novartis Investigator Site

    Großhansdorf

  • Novartis Investigator Site

    Hanover

  • Novartis Investigator Site

    Heidelberg

  • Novartis Investigator Site

    Leipzig

  • Novartis Investigator Site

    Mainz

  • Novartis Investigator Site

    Neu-Ulm

  • Novartis Investigator Site

    Neuss

  • Novartis Investigator Site

    Potsdam

  • Novartis Investigator Site

    Rostock

  • Novartis Investigator Site

    Schwabach

  • Novartis Investigator Site

    Schwetzingen

  • Novartis Investigator Site

    Straußberg

  • Novartis Investigative Site

    Wiesbaden

  • Novartis Investigator Site

    Wuppertal

Other trials in Germany

Spain13 sites

  • Novartis Investigator Site

    A Coruña

  • Novartis Investigative Site

    Alicante

  • Novartis Investigator Site

    Barcelona

  • Novartis Investigator Site

    Begonte

  • Novartis Investigator Site

    Cadiz

  • Novartis Investigator Site

    Granollers

  • Novartis Investigative Site

    Jaén

  • Novartis Investigator Site

    León

  • Novartis Investigator Site

    Madrid

  • Novartis Investigator Site

    Pamplona

  • Novartis Investigator Site

    Torrelavega

  • Novartis Investigator Site

    Valencia

  • Novartis Investigator Site

    Vigo

Other trials in Spain

Turkey (Türkiye)11 sites

  • Novartis Investigator Site

    Antalya

  • Novartis Investigator Site

    Çanakkale

  • Novartis Investigator Site

    Isparta

  • Novartis Investigator Site

    Istanbul

  • Novartis Investigator Site

    Kartal

  • Novartis Investigator Site

    Kayseri

  • Novartis Investigator Site

    Kozlu / Zonguldak

  • Novartis Investigator Site

    Malatya

  • Novartis Investigator Site

    Manisa

  • Novartis Investigator Site

    Mecidiyekoy/Istanbul

  • Novartis Investigator Site

    Yenisehir/Izmir

Other trials in Turkey (Türkiye)

Australia6 sites

  • Novartis Investigator Site

    Box Hill

  • Novartis Investigator Site

    Clayton

  • Novartis Investigator Site

    Garran

  • Novartis Investigator Site

    Glebe

  • Novartis Investigator Site

    Kogarah

  • Novartis Investigator Site

    Nedlands

Other trials in Australia

Argentina5 sites

  • Novartis Investigative Site

    Buenos Aires

  • Novartis Investigative Site

    Córdoba

  • Novartis Investigative Site

    Corrientes

  • Novartis Investigative SIte

    Mendoza

  • Novartis Investigative Site

    Rosario

Other trials in Argentina

Denmark5 sites

  • Novartis Investigator Site

    Copenhagen

  • Novartis Investigator Site

    Fredericia

  • Novartis Investigator Site

    Silkeborg

  • Novartis Investigator Site

    Soeborg

  • Novartis Investigator Site

    Vejle

Other trials in Denmark

South Africa5 sites

  • Novartis Investigator Site

    Cape Town

  • Novartis Investigator Site

    eManzimtoti

  • Novartis Investigator Site

    eMkhomazi

  • Novartis Investigator Site

    Johannesburg

  • Novartis Investigator Site

    Midrand

Other trials in South Africa

Colombia4 sites

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigator Site

    Bogotá

  • Novartis Investigative Site

    Medellín

Other trials in Colombia

Mexico4 sites

  • Novartis Investigative Site

    Guadalajara

  • Novartis Investigator Site

    Mexico City

  • Novartis Investigative Site

    Monterrey

  • Novartis Investigative Site

    Zapopan

Other trials in Mexico

Guatemala1 site

  • Novartis Investigative Site

    Guatemala City

Other trials in Guatemala

Philippines1 site

  • Novartis Investigator Site

    Manila

Other trials in Philippines

About this study

Official title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Being tested
Indacaterol 150 μg, Tiotropium 18 μg, Placebo to indacaterol
Keywords
chronic obstructive pulmonary disease, COPD, indacaterol, tiotropium, bronchodilation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

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

  • Indacaterol 150 μgDrug

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

  • Tiotropium 18 μgDrug

    Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).

  • Placebo to indacaterolDrug

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

Study groups in NCT00846586
Study groupRoleWhat they receive
Indacaterol 150 μg and tiotropium 18 μgExperimentalPatients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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: Tiotropium 18 μg
Tiotropium 18 μgActive comparatorPatients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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: Tiotropium 18 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 Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours 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, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)

Secondary outcomes (5)

  1. Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

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

  2. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 8 hours post-dose on Day 1

  3. Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: 24 hours post-dose on Day 2

  4. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 4 hours post-dose on Day 1

  5. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)

Timeline

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

  1. First posted18 Feb 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

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
1,134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00846586
Sponsor's protocol ID
CQAB149B2341
Acronym
INTRUST1
Status last verified
Jul 2011
First submitted
15 Feb 2009
Last updated
18 Aug 2011
Data monitoring committee
No

Publications

  • Mahler DA, D'Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B; INTRUST-1 and INTRUST-2 study investigators. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012 Sep;67(9):781-8. doi: 10.1136/thoraxjnl-2011-201140. Epub 2012 Apr 27.

    PubMed 22544891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 137 sites in 12 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 4 inclusion and 9 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 137 sites in United States, Germany, Spain, Turkey (Türkiye), Australia and 7 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 Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12) (time frame: From 5 minutes to 8 hours post-dose at the end of treatment (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 NCT00846586, 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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