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COPDPhase 3NCT00677807

Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Indacaterol in people with COPD, run by Novartis at 190 sites in 9 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 evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
Indacaterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
415 participants
Where
190 sitesin 9 countries
Study dates
May 2008to Mar 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

  • Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
  • In addition the following inclusion/exclusion criteria specified below must be met.
  • Patients must complete Stage 2 of the core study B2335S (NCT00463567).
  • Written informed consent to participate in the extension must be obtained.
  • Patients must be able to comply with all study requirements.

Who cannot join

  • Patients who were randomized to open-label tiotropium in Study B2335S.
  • Patients who participated in Stage 1 of the core study (B2335S).
  • Patients discontinued irrespective of the reason from Stage 2 of the core study.
  • Patients who fail to comply with the core protocol requirements and procedures.
  • Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
  • Patients who in the Investigator's opinion should not participate in the extension study.
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

190 sites in 9 countries.

190 sites in 9 countries

United States93 sites

  • Novartis Investigative Site

    Abingdon, Virginia, 24210

  • Novartis Investigative Site

    Atlanta, Georgia, 30342

  • Novartis Investigative Site

    Bellingham, Washington, 98225

  • Novartis Investigative Site

    Biddeford, Maine, 04005

  • Novartis Investigative Site

    Billings, Montana, 59102

  • Novartis Investigative Site

    Charlotte, North Carolina, 28207

  • Novartis Investigative Site

    Chesterfield, Missouri, 63017

  • Novartis Investigative Site

    Cincinnati, Ohio, 45245

  • Novartis Investgative Site

    Clarkston, Michigan, 48346

  • Novartis Investigative Site

    Clearwater, Florida, 33765

  • Novartis Investigative Site

    Cleveland, Ohio, 44109-1998

  • Novartis Investigative Site

    Columbia, Missouri, 65212

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Columbus, Ohio, 43215

  • Novartis Investigative Site

    Corsicana, Texas, 75110

  • Novartis Investigative site

    Cranston, Rhode Island, 02920

  • Novartis Investigative Site

    Crescent Springs, Kentucky, 41017

  • Novartis Investigative Site

    Cumberland, Rhode Island, 02864

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative site

    El Paso, Texas, 79902

  • Novartis Investigative Site

    Elmira, New York, 14905

  • Novartis Investigative Site

    Encinitas, California, 92024-1332

  • Novartis Investigative Site

    Erie, Pennsylvania, 16506

  • Novartis Investigative Site

    Eugene, Oregon, 97404-3233

  • Novartis Investigative Site

    Fargo, North Dakota, 58122

  • Novartis Investigative Site

    Flint, Michigan, 48532

  • Novartis Investigative site

    Fort Collins, Colorado, 80528

  • Novartis Investigative Site

    Fort Worth, Texas, 76104

  • Novartis Investigative SIte

    Fullerton, California, 92835

  • Novartis Investigative site

    Golden, Colorado, 80401

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigative site

    Henderson, Nevada, 89014

  • Novartis Investigative Site

    Homewood, Alabama, 35209-6870

  • Novartis Investigative Site

    Indianapolis, Indiana, 46256

  • Novartis Investigative Site

    Iowa City, Iowa, 52240

  • Novartis Investigative Site

    Iowa City, Iowa, 52242

  • Novartis Investigative Site

    Jasper, Alabama, 35501

  • Novartis Investigative Site

    Johnson City, Tennessee, 37601

  • Novartis Investigative Site

    Kalispell, Montana, 59901

  • Novartis Investigative Site

    Kansas City, Missouri, 64108-2677

  • Novartis Investigative Site

    Lafayette, Louisiana, 70503

  • Novartis Investigative Site

    Largo, Florida, 33770

  • Novartis Investigative Site

    Lexington, Kentucky, 40504

  • Novartis Investigative Site

    Lexington, Kentucky, 40536

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Livonia, Michigan, 48152

  • Novartis Investigative site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Marion, Ohio, 43302

  • Novartis Investigative Site

    Medford, Oregon, 97504-8741

  • Novartis Investigative Site

    Metaire, Louisiana, 70002

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53209-0996

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55407

  • Novartis Investigative site

    New Orleans, Louisiana, 70112

  • Novartis Investigative site

    New York, New York, 10016

  • Novartis Investigative Site

    Normal, Illinois, 61761

  • Novartis Investigative Site

    O'Fallon, Illinois, 62269

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73104

  • Novartis Investigative Site

    Omaha, Nebraska, 68130

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Omaha, Nebraska, 68198-5885

  • Novartis Investigative Site

    Orange, California, 92869

  • Novartis Investigative Site

    Papillion, Nebraska, 68046

  • Novartis Investigative Site

    Pensacola, Florida, 32504

  • Novartis Investigative Site

    Phoenix, Arizona, 85013

  • Novartis Investigative Site

    Pine Bluff, Arkansas, 71603

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15221

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15243

  • Novartis Investigative Site

    Richmond, Virginia, 23249

  • Novartis Investigative Site

    River Forest, Illinois, 60305

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Rochester, Minnesota, 55905

  • Novartis Investigative Site

    Rochester, New York, 14618-2638

  • Novartis Investigative Site

    Rockledge, Florida, 32955

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative site

    Spokane, Washington, 99216

  • Novartis Investigative Site

    Spring Valley, California, 91978

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative site

    Summit, New Jersey, 07901

  • Novartis Investigative Site

    Sylvania, Ohio, 43650

  • Novartis Investigative Site

    Tamarac, Florida, 33321

  • Novartis Investigative Site

    Tampa, Florida, 33603

  • Novartis Investigative Site

    Thornville, Ohio, 43076

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative site

    Troy, Michigan, 48085

  • Novartis Investigative Site

    Tucson, Arizona, 85712

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74135-2920

  • Novartis Investigative Site

    Wheat Ridge, Colorado, 80033

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

  • Novartis Investigative Site

    Zanesville, Ohio, 43701

Other trials in United States

Spain25 sites

  • Novartis Investigator Site

    A Coruña

  • Novartis Investigator Site

    Alicante

  • Novartis Investigator Site

    Alzira

  • Novartis Investigator Site

    Barcelona

  • Novartis Investigator Site

    Burgos

  • Novartis Investigator Site

    Córdoba

  • Novartis Investigator Site

    Girona

  • Novartis Investigator Site

    Gladakano

  • Novartis Investigator Site

    Jerez de Frontera

  • Novartis Investigator Site

    Las Palmas de Gran Canaria

  • Novartis Investigator Site

    Las Palmas de Gran Canarias

  • Novartis Investigator Site

    Lugo

  • Novartis Investigator Site

    Madrid

  • Novartis Investigator Site

    Málaga

  • Novartis Investigator Site

    Ourense

  • Novartis Investigator Site

    Oviedo

  • Novartis Investigator Site

    Palma de Mallorca

  • Novartis Investigator Site

    Ponferrada

  • Novartis Investigative Site

    Pontevedra

  • Novartis Investigator Site

    Port de Sagunt

  • Novartis Investigative Site

    Seville

  • Novartis Investigator Site

    Valencia

  • Novartis Investigator Site

    Vic

  • Novartis Investigator Site

    Vila-real

  • Novartis Investigative Site

    Zaragoza

Other trials in Spain

Germany18 sites

  • Novartis Investigative site

    Augsburg

  • Novartis Investigative site

    Bad Segeberg

  • Novartis Investigative site

    Berlin

  • Novartis Investigative site

    Bielefeld

  • Novartis Investigative site

    Bonn

  • Novartis Investigative site

    Dachau

  • Novartis Investigative site

    Hamburg

  • Novartis Investigative site

    Hoyerswerda

  • Novartis Investigative site

    Kaufbeuren

  • Novartis Investigative site

    Landsberg

  • Novartis Investigative site

    Leipzig

  • Novartis Investigative site

    Mainz

  • Novartis Investigative site

    München

  • Novartis Investigative site

    Oranienburg

  • Novartis Investigative site

    Oschersleben

  • Novartis Investigative site

    Potsdam

  • Novartis Investigative site

    Ratingen

  • Novartis Investigative site

    Steinfurt-Borghorst

Other trials in Germany

Canada17 sites

  • Novartis Investigative site

    Ajax

  • Novartis Investigative site

    Calgary

  • Novartis Investigative site

    Gatineau

  • Novartis Investigative site

    Moncton

  • Novartis Investigative site

    Montreal

  • Novartis Investigative site

    Niagara Falls

  • Novartis Investigative site

    Ottawa

  • Novartis Investigative site

    Québec

  • Novartis Investigative site

    Saint Romuald

  • Novartis Investigative site

    Saskatoon

  • Novartis Investigative site

    Sherbrooke

  • Novartis Investigative site

    St. John's

  • Novartis Investigative site

    Toronto

  • Novartis Investigative site

    Trois-Rivières

  • Novartis Investigative site

    Vancouver

  • Novartis Investigative site

    Windsor

  • Novartis Investigative site

    Winnipeg

Other trials in Canada

Italy14 sites

  • Novartis Investigator Site

    Bologna

  • Novartis Investigator Site

    Busto Arsizio

  • Novartis Investigator Site

    Catania

  • Novartis Investigator Site

    Catanzaro

  • Novartis Investigator Site

    Crema

  • Novartis Investigator Site

    Ferrara

  • Novartis Investigator Site

    Florence

  • Novartis Investigator Site

    Messina

  • Novartis Investigator Site

    Milan

  • Novartis Investigator Site

    Pisa

  • Novartis Investigator Site

    Roma

  • Novartis Investigator Site

    Rozzano

  • Novartis Investigator Site

    Siena

  • Novartis Investigator Site

    Sottomarina

Other trials in Italy

India12 sites

  • Novartis Investigator Site

    Bangalore

  • Novartis Investigative Site

    Chennai

  • Novartis Investigative Site

    Coimbatore

  • Novartis Investigator Site

    Coimbatore

  • Novartis Investigator Site

    Hyderabaad

  • Novartis Investigator Site

    Indore

  • Novartis Investigator Site

    Jaipur

  • Novartis Investigator Site

    Kolkata

  • Novartis Investigator Site

    Ludhiana

  • Novartis Investigative Site

    Mumbai

  • Novartis Investigator Site

    Panjim

  • Novartis Investigator Site

    Trivandrum

Other trials in India

Sweden6 sites

  • Novartis Investigative Site

    Gothenburg

  • Novartis Investigator Site

    Jönköping

  • Novartis Investigative Site

    Lidingö

  • Novartis Investigative Site

    Luleå

  • Novartis Investigator Site

    Luleå

  • Novartis Investigator Site

    Lund

Other trials in Sweden

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Kartal/Istanbul

  • Novartis Investigator Site

    Mersin

  • Novartis Investigator Site

    Yenisehir/Izmir

Other trials in Turkey (Türkiye)

Argentina2 sites

  • Novartis Investigative site

    Buenos Aires

  • Novartis Investigative site

    Rosario

Other trials in Argentina

About this study

Official title: A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Conditions
COPD
Being tested
Indacaterol, Placebo
Keywords
COPD, adults, β2-agonist, 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

    Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

  • PlaceboDrug

    Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Study groups in NCT00677807
Study groupRoleWhat they receive
Indacaterol 150 µgExperimentalIndacaterol 150 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Indacaterol
Indacaterol 300 µgExperimentalIndacaterol 300 µg once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI). The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Indacaterol
PlaceboPlacebo comparatorPlacebo once-daily (o.d.) via SDDPI. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Placebo

What is being measured

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

  1. The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

    The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.

    Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.

    High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.

    Measured: Up to 52 weeks

  2. The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

    The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.

    A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.

    A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.

    Measured: Up to 52 weeks

  3. The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

    The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.

    A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.

    A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.

    Measured: Up to 52 weeks

  4. The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo

    The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.

    The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).

    Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.

    Measured: Up to 52 weeks

  5. Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52

    The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.

    Measured: Weeks 12, 26, 36, 44 and 52

  6. Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52

    The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.

    Measured: Weeks 12, 26, 36, 44 and 52

Secondary outcomes (2)

  1. Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment

    Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.

    Measured: Week 52

  2. Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52

    The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.

    SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.

    Measured: Weeks 36, 44 and 52

Timeline

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

  1. First posted15 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2009
  4. Study completionMar 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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00677807
Sponsor's protocol ID
CQAB149B2335SE
Other IDs
2008-000663-42, 2008
Status last verified
Aug 2011
First submitted
13 May 2008
Last updated
22 Aug 2011
Data monitoring committee
No

Publications

  • Chapman KR, Rennard SI, Dogra A, Owen R, Lassen C, Kramer B; INDORSE Study Investigators. Long-term safety and efficacy of indacaterol, a long-acting beta(2)-agonist, in subjects with COPD: a randomized, placebo-controlled study. Chest. 2011 Jul;140(1):68-75. doi: 10.1378/chest.10-1830. Epub 2011 Feb 24.

    PubMed 21349928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol in people with COPD, run by Novartis at 190 sites in 9 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 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 22 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 190 sites in United States, Spain, Germany, Canada, Italy and 4 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. 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?

The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo (time frame: Up to 52 weeks). The study lists 6 primary outcomes in all. 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 NCT00677807, 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 22 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.

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