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Chronic Obstructive Pulmonary DiseasePhase 3NCT01072448

12-week Efficacy of Indacaterol

A Phase 3 study testing Indacaterol 75 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 62 sites in United States.

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 12-week study evaluated the efficacy and safety of indacaterol versus placebo. 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 75 μg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
323 participants
Where
62 sitesUnited States
Study dates
Jan 2010to Jul 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, 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%

Who cannot join

  • 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
  • Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

United States62 sites

  • Novartis Investigator Site

    Abingdon, Virginia, 24210

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Beaver, Pennsylvania, 15009

  • Novartis Investigator Site

    Bellevue, Nebraska, 68123

  • Novartis Investigator Site

    Buena Park, California, 90620

  • Novartis Investigator Site

    Champaign, Illinois, 61820

  • Novartis Investigative Site

    Charlotte, North Carolina, 28209

  • Novartis Investigative Site

    Cincinnati, Ohio, 45231

  • Novartis Investigative Site

    Clarkston, Michigan, 48346

  • Novartis Investigative Site

    Columbia, Maryland, 21044

  • Novartis Investigator Site

    Corsicana, Texas, 75110

  • Novartis Investigator Site

    Couer D'Alene, Idaho, 83814

  • Novartis Investigator Site

    Covington, Louisiana, 70433

  • Novartis Investigator Site

    Downers Grove, Illinois, 60515

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigator Site

    Encinitas, California, 92024

  • Novartis Investigative Site

    Erie, Pennsylvania, 16506

  • Novartis Investigative Site

    Flint, Michigan, 48532

  • Novartis Investigator Site

    Florissant, Missouri, 63033

  • Novartis Investigator Site

    Fort Worth, Texas, 76109

  • Novartis Investigator Site

    Fountain Valley, California, 92708

  • Novartis Investigative Site

    Gaffney, South Carolina, 29340

  • Novartis Investigative site

    Greer, South Carolina, 29651

  • Novartis Investigator Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Johnson City, Tennessee, 37601

  • Novartis Investigative site

    Lexington, Kentucky, 40504

  • Novartis Investigator Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Livonia, Michigan, 48152

  • Novartis Investigator Site

    Los Angeles, California, 90015

  • Novartis Investigator Site

    Medford, Oregon, 97504

  • Novartis Investigator Site

    Metaire, Louisiana, 70002

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigative Site

    Missoula, Montana, 59808

  • Novartis Investigative Site

    New Brunswick, New Jersey, 08902

  • Novartis Investigative Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Ocean City, New Jersey, 07712

  • Novartis Investigator Site

    Omaha, Nebraska, 68134

  • Novartis Investigator Site

    Ozark, Missouri, 65721

  • Novartis Investigator Site

    Pahrump, Nevada, 89048

  • Novartis Investigator Site

    Peoria, Arizona, 85381

  • Novartis Investigator Site

    Pine Bluff, Arkansas, 71603

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15221

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15243

  • Novartis Investigative Site

    Plymouth, Minnesota, 55441

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    River Forest, Illinois, 60305

  • Novartis Investigative Site

    Rochester, New York, 14618

  • Novartis Investigative Site

    Salisbury, North Carolina, 28144

  • Novartis Investigator Site

    Salt Lake City, Utah, 84107

  • Novartis Investigator Site

    San Diego, California, 92103

  • Novartis Investigator Site

    San Diego, California, 92120

  • Novartis Investigative Site

    Sarasota, Florida, 34233

  • Novartis Investigative Site

    Seneca, South Carolina, 29678

  • Novartis Investigator Site

    Skokie, Illinois, 60076

  • Novartis Investigator Site

    Springfield, Illinois, 62703

  • Novartis Investigator Site

    St Louis, Missouri, 63117

  • Novartis Investigator Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigator Site

    Temecula, California, 92591

  • Novartis Investigator Site

    Torrance, California, 90505

  • Novartis Investigator Site

    Walnut Creek, California, 94598

  • Novartis Investigator Site

    Wheat Ridge, Colorado, 80033

Other trials in United States

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 Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Being tested
Indacaterol 75 μg, Placebo to indacaterol
Keywords
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 75 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 NCT01072448
Study groupRoleWhat they receive
Indacaterol 75 μgExperimentalPatients 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.
Receives: Drug: Indacaterol 75 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 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.

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

Secondary outcomes (1)

  1. Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)

    An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, 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.

    Measured: End of the study (Week 12, Day 84)

Timeline

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

  1. First posted22 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2010
  4. Study completionJul 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
323 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01072448
Sponsor's protocol ID
CQAB149B2354
Status last verified
Jul 2011
First submitted
19 Feb 2010
Last updated
19 Aug 2011

Publications

  • 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.

    PubMed 23020650

  • Kerwin 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.

    PubMed 22177371

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 75 μg in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 62 sites in United States.

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 7 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 19 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 62 sites in United States. 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 19 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 NCT01072448, which also lists 2 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 19 Aug 2011.

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