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Chronic Obstructive Pulmonary DiseasePhase 3NCT00624286

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Indacaterol 150 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 120 sites in 3 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 was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Indacaterol 150 μg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
120 sitesin 3 countries
Study dates
Feb 2008to Jul 2008
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

  • Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus
  • 20 pack-year smoking history
  • Signed informed consent
  • Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%

Who cannot join

  • History of asthma
  • Prior exposure to indacaterol
  • Active cancer or history of cancer
  • Patients with concomitant pulmonary disease
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
  • 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

120 sites in 3 countries.

120 sites in 3 countries

United States118 sites

  • Novartis Investigative Site

    Abingdon, Virginia, 24210-2921

  • Novartis Investigative Site

    Amarillo, Texas, 79106

  • Novartis Investigative Site

    Ames, Iowa, 50010

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48105-9755

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigative Site

    Austell, Georgia, 30106-1110

  • Novartis Investigative Site

    Birmingham, Alabama, 35209-6870

  • Novartis Investigative Site

    Buena Park, California, 90620

  • Novartis Investigative Site

    Charleston, South Carolina, 29412

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Charlotte, North Carolina, 28277

  • Novartis Investigative Site

    Cherry Hill, New Jersey, 08003

  • Novartis Investigative Site

    Cincinnati, Ohio, 45227

  • Novartis Investigative Site

    Cincinnati, Ohio, 45231

  • Novartis Investigator Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Clarkston, Michigan, 48346

  • Novartis Investigative Site

    Clearwater, Florida, 33765

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Cortland, New York, 13045

  • Novartis Investigative Site

    Crescent Springs, Kentucky, 41017

  • Novartis Investigative Site

    Cumberland, Rhode Island, 02864

  • Novartis Investigator Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    El Paso, Texas, 79902-5107

  • Novartis Investigative Site

    Encinitas, California, 92024-1332

  • Novartis Investigative Site

    Erie, Pennsylvania, 15608

  • Novartis Investigative Site

    Eugene, Oregon, 97404

  • Novartis Investigative Site

    Flint, Michigan, 58532

  • Novartis Investigative Site

    Fort Collins, Colorado, 80528-3400

  • Novartis Investigative Site

    Fort Worth, Texas, 76104-4185

  • Novartis Investigative Site

    Fresno, California, 93710

  • Novartis Investigative Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Gaffney, South Carolina, 29340

  • Novartis Investigator Site

    Glendale, Arizona, 85306

  • Novartis Investigative Site

    Golden, Colorado, 80401

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigative Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    High Point, North Carolina, 27262-4320

  • Novartis Investigative Site

    Homestead, Pennsylvania, 15120

  • Novartis Investigative Site

    Indianapolis, Indiana, 46285

  • Novartis Investigative Site

    Iowa City, Iowa, 52240

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Johnson City, Tennessee, 37601

  • Novartis Investigative Site

    Kalispell, Montana, 59901

  • Novartis Investigative Site

    Largo, Florida, 33770-2335

  • Novartis Investigative Site

    Las Vegas, Nevada, 89102-4508

  • Novartis Investigative Site

    Lexington, Kentucky, 40504

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Livonia, Michigan, 48152

  • Novartis Investigative Site

    Los Angeles, California, 90048

  • Novartis Investigative Site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Madisonville, Kentucky, 42431

  • Novartis Investigative Site

    Marion, Ohio, 43302

  • Novartis Investigative Site

    Medford, Oregon, 97504-9741

  • Novartis Investigative Site

    Metairie, Louisiana, 70006-4225

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53209

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407

  • Novartis Investigative Site

    Missoula, Montana, 59808

  • Novartis Investigative Site

    Mobile, Alabama, 36608-6705

  • Novartis Investigative Site

    Morgantown, West Virginia, 26505-2713

  • Novartis Investigative Site

    New Braunfels, Texas, 78130-6113

  • Novartis Investigative Site

    Newark, Delaware, 19713

  • Novartis Investigative Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    North Charleston, South Carolina, 29406-9167

  • Novartis Investigative Site

    O'Fallon, Illinois, 62269

  • Novartis Investigative Site

    Ocala, Florida, 34471

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73112

  • Novartis Investigative Site

    Omaha, Nebraska, 68114-3570

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Opelousas, Louisiana, 70570

  • Novartis Investigative Site

    Orange, California, 92869

  • Novartis Investigative Site

    Palmdale, California, 93551-1411

  • Novartis Investigative Site

    Payson, Utah, 84651

  • Novartis Investigative Site

    Pensacola, Florida, 32503

  • Novartis Investigative Site

    Pensacola, Florida, 32504-8756

  • Novartis Investigative Site

    Pensacola, Florida, 32504

  • Novartis Investigative Site

    Phoenix, Arizona, 85006-2611

  • Novartis Investigative Site

    Phoenix, Arizona, 85013-4232

  • Novartis Investigative Site

    Pine Bluff, Arkansas, 71603

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15243-1800

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Richmond, Virginia, 23229

  • Novartis Investigative Site

    Richmond, Virginia, 23298

  • Novartis Investigative Site

    River Forest, Illinois, 60305

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Rochester, New York, 14618

  • Novartis Investigative Site

    Rockledge, Florida, 32955

  • Novartis Investigative Site

    Saint Charles, Missouri, 63301-2847

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Jose, California, 95117

  • Novartis Investigative Site

    San Mateo, California, 94401

  • Novartis Investigator Site

    Sarasota, Florida, 34233-1272

  • Novartis Investigative Site

    Shawnee, Kansas, 66216-1800

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigative Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29303

  • Novartis Investigative Site

    Spokane, Washington, 99201

  • Novartis Investigative Site

    Spokane Valley, Washington, 99216-1092

  • Novartis Investigator Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Stockton, California, 95207

  • Novartis Investigative Site

    Summit, New Jersey, 07901

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Tampa, Florida, 33603

  • Novartis Investigative Site

    Thornville, Ohio, 43076-8010

  • Novartis Investigative Site

    Torrance, California, 90503

  • Novartis Investigative Site

    Troy, Michigan, 48085

  • Novartis Investigative Site

    Tucson, Arizona, 85712

  • Novartis Investigative Site

    Tucson, Arizona, 85723

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74135-2920

  • Novartis Investigative Site

    Union, South Carolina, 29379

  • Novartis Investigative Site

    Vista, California, 92083

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigator Site

    Wheat Ridge, Colorado, 80033-4300

  • Novartis Investigative Site

    Worcester, Massachusetts, 01605

  • Novartis Investigative Site

    Zephyrhills, Florida, 33542-7505

Other trials in United States

Belgium1 site

  • Novartis Investigative Site

    Lanaken

Other trials in Belgium

New Zealand1 site

  • Novartis Investigator Site

    Tauranga

Other trials in New Zealand

About this study

Official title: A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Being tested
Indacaterol 150 μg, Placebo to indacaterol
Keywords
chronic obstructive pulmonary disease, COPD, indacaterol
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.

  • 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 NCT00624286
Study groupRoleWhat they receive
Indacaterol 150 μgExperimentalPatients inhaled indacaterol 150 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.
Receives: Drug: Indacaterol 150 μg
Placebo to indacaterolPlacebo 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.
Receives: Drug: Placebo to indacaterol

What is being measured

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

  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 30 minutes post-dose of salbutamol 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 the study (Week 12 + 1 day, Day 85)

Secondary outcomes (1)

  1. 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. 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 30 minutes post-dose of salbutamol 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

Timeline

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

  1. First posted27 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2008
  4. Study completionJul 2008

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
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00624286
Sponsor's protocol ID
CQAB149B2346
Other IDs
EUDRACT Number: 2008-000301-11
Status last verified
Jul 2011
First submitted
15 Feb 2008
Last updated
18 Aug 2011
Data monitoring committee
No

Publications

  • Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.

    PubMed 22206353

  • Bleecker ER, Siler T, Owen R, Kramer B. Bronchodilator efficacy and safety of indacaterol 150 mug once daily in patients with COPD: an analysis of pooled data. Int J Chron Obstruct Pulmon Dis. 2011;6:431-8. doi: 10.2147/COPD.S21073. Epub 2011 Aug 18.

    PubMed 22003288

  • Feldman G, Siler T, Prasad N, Jack D, Piggott S, Owen R, Higgins M, Kramer B; INLIGHT 1 study group. Efficacy and safety of indacaterol 150 microg once-daily in COPD: a double-blind, randomised, 12-week study. BMC Pulm Med. 2010 Mar 8;10:11. doi: 10.1186/1471-2466-10-11.

    PubMed 20211002

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 120 sites in 3 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 8 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 120 sites in United States, Belgium, New Zealand. 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. Some participants in this study may receive a placebo. 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?

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85) (time frame: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)). 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 NCT00624286, which also lists 3 linked publications.

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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