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

NCT ID: NCT00567996

Last Updated: 2011-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Indacaterol 150 μg

Indacaterol 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.

Group Type EXPERIMENTAL

Indacaterol 150 μg

Intervention Type DRUG

Indacaterol 150 μg once daily (o.d) inhaled

Placebo to Salmeterol

Intervention Type DRUG

Placebo to salmeterol delivered via a proprietary dry powder inhaler

Placebo

Placebo 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.

Group Type PLACEBO_COMPARATOR

Placebo to Indacaterol

Intervention Type DRUG

Placebo to Indacaterol inhaled via SDDPI.

Placebo to Salmeterol

Intervention Type DRUG

Placebo to salmeterol delivered via a proprietary dry powder inhaler

Salmeterol 50 μg

Salmeterol 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.

Group Type ACTIVE_COMPARATOR

Salmeterol 50 μg

Intervention Type DRUG

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

Placebo to Indacaterol

Intervention Type DRUG

Placebo to Indacaterol inhaled via SDDPI.

Interventions

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Indacaterol 150 μg

Indacaterol 150 μg once daily (o.d) inhaled

Intervention Type DRUG

Salmeterol 50 μg

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

Intervention Type DRUG

Placebo to Indacaterol

Placebo to Indacaterol inhaled via SDDPI.

Intervention Type DRUG

Placebo to Salmeterol

Placebo to salmeterol delivered via a proprietary dry powder inhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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novartis

Principal Investigators

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Novartis Pharma AG

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Edmonton, , Canada

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Edmonton, , Canada

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London, , Canada

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Mirabel, , Canada

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Montreal, , Canada

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Toronto, , Canada

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Barranquilla, , Colombia

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Bogota D.C., , Colombia

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Medellín, , Colombia

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Cvikov, , Czechia

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Lovosice, , Czechia

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Novy Jocin, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Žatec, , Czechia

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Aalborg, , Denmark

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Copenhagen, , Denmark

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Frederikssund, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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Odense, , Denmark

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Roslev, , Denmark

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Silkeborg, , Denmark

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Søborg, , Denmark

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Vaerloese, , Denmark

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Hus, , Finland

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Jyväskylä, , Finland

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Lahti, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Turku, , Finland

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Ambroise, , France

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Beuvry, , France

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Férolles-Attilly, , France

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Nice, , France

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Bad Segeberg, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Bonn, , Germany

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Brühl, , Germany

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Cologne, , Germany

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Cottbus, , Germany

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Dortmund, , Germany

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Düren, , Germany

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Eggenfelden, , Germany

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Eschwege, , Germany

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Forchheim, , Germany

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Freudenberg, , Germany

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Fürth, , Germany

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Gelsenkirchen, , Germany

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Gummersbach, , Germany

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Hagen, , Germany

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Hanover, , Germany

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Kassel, , Germany

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Kempten, , Germany

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Landsberg am Lech, , Germany

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Langenfeld, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Munich, , Germany

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München, , Germany

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Neuss, , Germany

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Nuremberg, , Germany

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Oschersleben, , Germany

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Ruhmannsfelden, , Germany

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Sinsheim, , Germany

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Solingen, , Germany

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Steinfort-borghorst, , Germany

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Vilshofen, , Germany

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Wallerfing, , Germany

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Witten, , Germany

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Budapest, , Hungary

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Debrechen, , Hungary

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Deszk, , Hungary

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Mosonmagyaróvár, , Hungary

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Székesfehérvár, , Hungary

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Reykhavik, , Iceland

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Chennai, , India

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Coimbatore, , India

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Goa, , India

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Hyderabad, , India

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Jaipur, , India

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Kerala, , India

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Mangalore, , India

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Mumbai, , India

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Vellore, , India

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Ancona, , Italy

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Arenzano, , Italy

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Ascoli Piceno, , Italy

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Brescia, , Italy

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Cagliari, , Italy

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Chieti, , Italy

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Ferrara, , Italy

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Milan, , Italy

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Milan, , Italy

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Orbassano, , Italy

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Palermo, , Italy

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Reggio Emilia, , Italy

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Rome, , Italy

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Sexten, , Italy

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Siena, , Italy

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Terni, , Italy

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Callao, , Peru

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Miraflores, , Peru

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San Borja, , Peru

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San Isidro, , Peru

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San Martín de Porres, , Peru

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Surco, , Peru

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Kovice, , Slovakia

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Spišská Nová Ves, , Slovakia

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Kaohusing, , Taiwan

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Lin-ko, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Countries

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Canada Colombia Czechia Denmark Finland France Germany Hungary Iceland India Italy Peru Russia Slovakia Taiwan

References

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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.

Reference Type DERIVED
PMID: 22158330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21397482 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21227674 (View on PubMed)

Other Identifiers

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CQAB149B2336

Identifier Type: -

Identifier Source: org_study_id

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