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Chronic Obstructive Pulmonary DiseasePhase 3NCT01068600

Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

A Phase 3 study testing Indacaterol in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 54 sites in United States.

Completed

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

Official record
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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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
318 participants
Where
54 sitesUnited States
Study dates
Jan 2010to Jun 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 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 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 for 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 comorbid conditions
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Novartis Investigator Site

    Albuquerque, New Mexico, 87108

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigator Site

    Arlington, Texas, 76012

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigator Site

    Baton Rouge, Louisiana, 70808

  • Novartis Investigative Site

    Canton, Ohio, 44718

  • Novartis Investigative Site

    Charleston, South Carolina, 29407

  • 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, 45242

  • Novartis Investigative Site

    Clearwater, Florida, 33756

  • Novartis Investigative Site

    Clearwater, Florida, 33765

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Cumberland, Rhode Island, 02864

  • Novartis Investigator Site

    Dickinson, Texas, 77539

  • Novartis Investigative Site

    Easley, South Carolina, 29640

  • Novartis Investigator Site

    El Paso, Texas, 79903

  • Novartis Investigator Site

    Eugene, Oregon, 97404

  • Novartis Investigator Site

    Fullerton, California, 92835

  • Novartis Investigator Site

    Glendale, Arizona, 85306

  • Novartis Investigative site

    Greenville, South Carolina, 29615

  • Novartis Investigator Site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigator Site

    Iowa City, Iowa, 52242

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigator Site

    Las Vegas, Nevada, 89119

  • Novartis Investigator Site

    Lincoln, Nebraska, 68510

  • Novartis Investigator Site

    Los Angeles, California, 90048

  • Novartis Investigator Site

    Los Angeles, California, 90095

  • Novartis Investigative Site

    Madisonville, Kentucky, 42431

  • Novartis Investigator Site

    Marion, Ohio, 43302

  • Novartis Investigator Site

    McKinney, Texas, 75069

  • Novartis Investigator Site

    Medford, Oregon, 97504

  • Novartis Investigative site

    Miami, Florida, 33145

  • Novartis Investigator Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    North Charleston, South Carolina, 29406

  • Novartis Investigator Site

    Omaha, Nebraska, 68114

  • Novartis Investigator Site

    Omaha, Nebraska, 68134

  • Novartis Investigator Site

    Opelousas, Louisiana, 70570

  • Novartis Investigative Site

    Pawtucket, Rhode Island, 02860

  • Novartis Investigator Site

    Phoenix, Arizona, 85006

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Richmond, Virginia, 23229

  • Novartis Investigator Site

    Riverside, California, 92506

  • Novartis Investigator Site

    Saint Charles, Missouri, 63301

  • Novartis Investigative Site

    Shelby, North Carolina, 28152

  • Novartis Investigative Site

    South Burlington, Vermont, 05403

  • Novartis Investigative Site

    Spartanburg, South Carolina, 29303

  • Novartis Investigator Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Tampa, Florida, 33603

  • Novartis Investigative Site

    Union, South Carolina, 29379

  • Novartis Investigative Site

    Winter Park, Florida, 32789

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, 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.

  • IndacaterolDrug

    Once daily via single-dose dry powder inhaler (SDDPI)

  • Placebo to indacaterolDrug

    Once daily via SDDPI

Study groups in NCT01068600
Study groupRoleWhat they receive
Indacaterol 75 µgExperimentalIndacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Receives: Drug: Indacaterol
PlaceboPlacebo comparatorPlacebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) 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) After 12 Weeks of Treatment

    Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

    Measured: after 12 weeks

Secondary outcomes (1)

  1. Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment

    TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.

    Measured: after 12 weeks

Timeline

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

  1. First posted15 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 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
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01068600
Sponsor's protocol ID
CQAB149B2355
Status last verified
Jul 2011
First submitted
12 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 in people with Chronic Obstructive Pulmonary Disease, run by Novartis at 54 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 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 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 54 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) After 12 Weeks of Treatment (time frame: after 12 weeks). 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 NCT01068600, 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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