AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT00567996

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

A Phase 3 study testing Indacaterol 150 μg and Salmeterol 50 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 128 sites in 15 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 safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Indacaterol 150 μg and Salmeterol 50 μg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,002 participants
Where
128 sitesin 15 countries
Study dates
Nov 2007to Jan 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

  • Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:
  • Smoking history of at least 20 pack years
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
  • Post-bronchodilator FEV1/FVC < 70%
  • ("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Who cannot join

  • Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
  • Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
  • Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
  • Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
  • Concomitant pulmonary disease
  • Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
Show all 14Show fewer
  • History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
  • Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
  • History of reactions to sympathomimetic amines or inhaled medication
  • Inability to use the dry powder devices or perform spirometry
  • Irregular day/night, wake/sleep cycles, e.g. shift workers
  • Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
  • Patients unable or unwilling to complete a patient diary
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

128 sites in 15 countries.

128 sites in 15 countries

Germany37 sites

  • Novartis Investigator Site

    Bad Segeberg

  • Novartis Investigator Site

    Berlin

  • Novartis Investigator Site

    Bielefeld

  • Novartis Investigator Site

    Bochum

  • Novartis Investigator Site

    Bonn

  • Novartis Investigator Site

    Brühl

  • Novartis Investigator Site

    Cologne

  • Novartis Investigator Site

    Cottbus

  • Novartis Investigator Site

    Dortmund

  • Novartis Investigator Site

    Düren

  • Novartis Investigator Site

    Eggenfelden

  • Novartis investigator site

    Eschwege

  • Novartis Investigator Site

    Forchheim

  • Novartis Investigator Site

    Freudenberg

  • Novartis Investigator Site

    Fürth

  • Novartis Investigator Site

    Gelsenkirchen

  • Novartis Investigator Site

    Gummersbach

  • Novartis Investigator Site

    Hagen

  • Novartis Investigator Site

    Hanover

  • Novartis Investigator Site

    Kassel

  • Novartis Investigator Site

    Kempten

  • Novartis Investigator Site

    Landsberg am Lech

  • Novartis Investigator Site

    Langenfeld

  • Novartis Investigator Site

    Leipzig

  • Novartis Investigator Site

    Mainz

  • Novartis Investigator Site

    München

  • Novartis Investigator Site

    Munich

  • Novartis Investigator Site

    Neuss

  • Novartis Investigator Site

    Nuremberg

  • Novartis Investigator Site

    Oschersleben

  • Novartis Investigator Site

    Ruhmannsfelden

  • Novartis Investigator site

    Sinsheim

  • Novartis Investigator Site

    Solingen

  • Novartis Investigator Site

    Steinfort-borghorst

  • Novartis Investigator Site

    Vilshofen

  • Novartis Investigator Site

    Wallerfing

  • Novartis Investigator Site

    Witten

Other trials in Germany

Italy16 sites

  • Novartis Investigator Site

    Ancona

  • Novartis Investigator Site

    Arenzano

  • Novartis Investigative Site

    Ascoli Piceno

  • Novartis Investigator Site

    Brescia

  • Novartis Investigator Site

    Cagliari

  • Novartis investigator site

    Chieti

  • Novartis Investigator Site

    Ferrara

  • Novartis Investigator Site

    Milan

  • Novartis Investigator Site

    Milan

  • Novartis Investigator Site

    Orbassano

  • Novartis Investigator Site

    Palermo

  • Novartis Investigator Site

    Reggio Emilia

  • Novartis Investigator Site

    Rome

  • Novartis Investigator Site

    Sexten

  • Novartis Investigator Site

    Siena

  • Novartis Investigator Site

    Terni

Other trials in Italy

Denmark12 sites

  • Novartis Investigator Site

    Aalborg

  • Novartis Investigator Site

    Aarhus

  • Novartis Investigative Site

    Copenhagen

  • Novartis Investigator Site

    Copenhagen

  • Novartis Investigator Site

    Frederikssund

  • Novartis investigator site

    Hellerup

  • Novartis Investigator site

    Hvidovre

  • Novartis investigator site

    Odense

  • Novartis Investigator Site

    Roslev

  • Novartis Investigative Site

    Silkeborg

  • Novartis Investgative Site

    Søborg

  • Novartis Investigator Site

    Vaerloese

Other trials in Denmark

India9 sites

  • Novartis Investigator Site

    Chennai

  • Novartis Investigator Site

    Coimbatore

  • Novartis Investigator Site

    Goa

  • Novartis Investigator Site

    Hyderabad

  • Novartis Investigator Site

    Jaipur

  • Novartis Investigator Site

    Kerala

  • Novartis Investigator Site

    Mangalore

  • Novartis Investigator Site

    Mumbai

  • Novartis Investigator Site

    Vellore

Other trials in India

Canada6 sites

  • Novartis Investigative Site

    Edmonton

  • Novartis Investigator Site

    Edmonton

  • Novartis Investigator Site

    London

  • Novartis Investigator Site

    Mirabel

  • Novartis Investigator Site

    Montreal

  • Novartis Investigator Site

    Toronto

Other trials in Canada

Czechia6 sites

  • Novartis Investigator Site

    Cvikov

  • Novartis Investigator Site

    Lovosice

  • novartis Investigator site

    Novy Jocin

  • Novartis Investigator Site

    Pardubice

  • Novartis Investigator Site

    Prague

  • Novartis Investigative Site

    Žatec

Other trials in Czechia

Finland6 sites

  • Novartis Investigator Site

    Hus

  • Novartis Investigator Site

    Jyväskylä

  • Novartis Investigator Site

    Lahti

  • Novartis Investigator Site

    Oulu

  • Novartis Investigator Site

    Tampere

  • Novartis Investigator Site

    Turku

Other trials in Finland

Peru6 sites

  • Novartis Investigator Site

    Callao

  • Novartis Investigator Site

    Miraflores

  • Novartis Investigator Site

    San Borja

  • Novartis Investigator Site

    San Isidro

  • Novartis Investigator Site

    San Martín de Porres

  • Novartis Investigator Site

    Surco

Other trials in Peru

Russia6 sites

  • Novartis Investigator Site

    Kazan'

  • Novartis Investigator Site

    Moscow

  • Novartis Investigator Site

    Saint Petersburg

  • Novartis Investigator Site

    Samara

  • Novartis Investigator Site

    Yaroslavl

  • Novartis Investigator Site

    Yekaterinburg

Other trials in Russia

Taiwan6 sites

  • Novartis Investigator Site

    Changhua

  • Novartis Investigator Site

    Kaohsiung City

  • Novartis Investigator Site

    Kaohusing

  • Novartis Investigator Site

    Lin-ko

  • Novartis Investigator Site

    Taichung

  • Novartis Investigator Site

    Taipei

Other trials in Taiwan

Hungary5 sites

  • Novartis Investigator Site

    Budapest

  • Novartis investigator site

    Debrechen

  • Novartis Investigator Site

    Deszk

  • Novartis Investigator Site

    Mosonmagyaróvár

  • Novartis Investigator Site

    Székesfehérvár

Other trials in Hungary

Slovakia5 sites

  • Novartis Investigator Site

    Bardejov

  • Novartis Investigator Site

    Bratislava

  • Novartis Investigator Site

    Košice

  • Novartis Investigator Site

    Kovice

  • Novartis Investigator Site

    Spišská Nová Ves

Other trials in Slovakia

France4 sites

  • Novartis Investigative Site

    Ambroise

  • Novartis Investigative Site

    Beuvry

  • Novartis Investgative Site

    Férolles-Attilly

  • Novartis Investigator Site

    Nice

Other trials in France

Colombia3 sites

  • Novartis Investigator site

    Barranquilla

  • Novartis Investigator Site

    Bogota D.C.

  • Novartis Investigator Site

    Medellín

Other trials in Colombia

Iceland1 site

  • Novartis investigator site

    Reykhavik

Other trials in Iceland

About this study

Official title: A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Being tested
Indacaterol 150 μg, Salmeterol 50 μg, Placebo to Indacaterol, Placebo to Salmeterol
Keywords
Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled
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 150 μg once daily (o.d) inhaled

  • Salmeterol 50 μgDrug

    Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

  • Placebo to IndacaterolDrug

    Placebo to Indacaterol inhaled via SDDPI.

  • Placebo to SalmeterolDrug

    Placebo to salmeterol delivered via a proprietary dry powder inhaler

Study groups in NCT00567996
Study groupRoleWhat they receive
Indacaterol 150 μgExperimentalIndacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Indacaterol 150 μg; Drug: Placebo to Salmeterol
PlaceboPlacebo comparatorPlacebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Placebo to Indacaterol; Drug: Placebo to Salmeterol
Salmeterol 50 μgActive comparatorSalmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Salmeterol 50 μg; 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 salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.

    Measured: Week 12

Secondary outcomes (2)

  1. St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment

    SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.

    Measured: Week 12

  2. Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment

    Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.

    Measured: Up to 26 weeks

Timeline

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

  1. First posted5 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJan 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
1,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00567996
Sponsor's protocol ID
CQAB149B2336
Status last verified
Jul 2011
First submitted
4 Dec 2007
Last updated
18 Aug 2011

Publications

  • Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.

    PubMed 22158330

  • Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.

    PubMed 21397482

  • Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.

    PubMed 21227674

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 μg and Salmeterol 50 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis at 128 sites in 15 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 14 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 128 sites in Germany, Italy, Denmark, India, Canada and 10 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?

Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (time frame: Week 12). 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 NCT00567996, 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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in