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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: Indacaterol 150 μg (Drug); Salmeterol 50 μg (Drug); Placebo to Indacaterol (Drug); Placebo to Salmeterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharma AG, Study Chair, Affiliation: Novartis Pharmaceuticals

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment

Secondary outcome:

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

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

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Edmonton, Canada

Novartis Investigator Site, Edmonton, Canada

Novartis Investigator Site, London, Canada

Novartis Investigator Site, Mirabel, Canada

Novartis Investigator Site, Montreal, Canada

Novartis Investigator Site, Toronto, Canada

Novartis Investigator site, Barranquilla, Colombia

Novartis Investigator Site, Bogota D.C., Colombia

Novartis Investigator Site, Medellin, Colombia

Novartis Investigator Site, Cvikov, Czech Republic

Novartis Investigator Site, Lovosice, Czech Republic

novartis Investigator site, Novy Jocin, Czech Republic

Novartis Investigator Site, Pardubice, Czech Republic

Novartis Investigator Site, Praha, Czech Republic

Novartis Investigative Site, Zatec, Czech Republic

Novartis Investigator Site, Aalborg, Denmark

Novartis Investigator Site, Arhus, Denmark

Novartis Investigative Site, Copenhagen, Denmark

Novartis Investigator Site, Copenhagen, Denmark

Novartis Investigator Site, Frederikssund, Denmark

Novartis investigator site, Hellerup, Denmark

Novartis Investigator site, Hvidovre, Denmark

Novartis investigator site, Odense, Denmark

Novartis Investigator Site, Roslev, Denmark

Novartis Investigative Site, Silkeborg, Denmark

Novartis Investgative Site, Soborg, Denmark

Novartis Investigator Site, Vaerloese, Denmark

Novartis Investigator Site, Hus, Finland

Novartis Investigator Site, Jyvaskyla, Finland

Novartis Investigator Site, Lahti, Finland

Novartis Investigator Site, Oulu, Finland

Novartis Investigator Site, Tampere, Finland

Novartis Investigator Site, Turku, Finland

Novartis Investigative Site, Ambroise, France

Novartis Investigative Site, Beuvry, France

Novartis Investgative Site, Ferolles-Attilly, France

Novartis Investigator Site, Nice, France

Novartis Investigator Site, Bad Segeberg, Germany

Novartis Investigator Site, Berlin, Germany

Novartis Investigator Site, Bielefeld, Germany

Novartis Investigator Site, Bochum, Germany

Novartis Investigator Site, Bonn, Germany

Novartis Investigator Site, Bruehl, Germany

Novartis Investigator Site, Cottbus, Germany

Novartis Investigator Site, Dortmund, Germany

Novartis Investigator Site, Dueren, Germany

Novartis Investigator Site, Eggenfelden, Germany

Novartis investigator site, Eschwege, Germany

Novartis Investigator Site, Forchheim, Germany

Novartis Investigator Site, Freudenberg, Germany

Novartis Investigator Site, Furth, Germany

Novartis Investigator Site, Gelsenkirchen, Germany

Novartis Investigator Site, Gummersbach, Germany

Novartis Investigator Site, Hagen, Germany

Novartis Investigator Site, Hannover, Germany

Novartis Investigator Site, Kassel, Germany

Novartis Investigator Site, Kempten, Germany

Novartis Investigator Site, Koeln, Germany

Novartis Investigator Site, Landsberg am Lech, Germany

Novartis Investigator Site, Langenfeld, Germany

Novartis Investigator Site, Leipzig, Germany

Novartis Investigator Site, Mainz, Germany

Novartis Investigator Site, Muenchen, Germany

Novartis Investigator Site, Munich, Germany

Novartis Investigator Site, Neuss, Germany

Novartis Investigator Site, Nuremburg, Germany

Novartis Investigator Site, Oschersleben, Germany

Novartis Investigator Site, Ruhmannsfelden, Germany

Novartis Investigator site, Sinsheim, Germany

Novartis Investigator Site, Solingen, Germany

Novartis Investigator Site, Steinfort-borghorst, Germany

Novartis Investigator Site, Vilshofen, Germany

Novartis Investigator Site, Wallerfing, Germany

Novartis Investigator Site, Witten, Germany

Novartis Investigator Site, Budapest, Hungary

Novartis investigator site, Debrechen, Hungary

Novartis Investigator Site, Deszk, Hungary

Novartis Investigator Site, Mosonmagyarovar, Hungary

Novartis Investigator Site, Szekesfehervar, Hungary

Novartis investigator site, Reykhavik, Iceland

Novartis Investigator Site, Chennai, India

Novartis Investigator Site, Coimbatore, India

Novartis Investigator Site, Goa, India

Novartis Investigator Site, Hyderabad, India

Novartis Investigator Site, Jaipur, India

Novartis Investigator Site, Kerala, India

Novartis Investigator Site, Mangalore, India

Novartis Investigator Site, Mumbai, India

Novartis Investigator Site, Vellore, India

Novartis Investigator Site, Ancona, Italy

Novartis Investigator Site, Arenzano, Italy

Novartis Investigative Site, Ascoli Piceno, Italy

Novartis Investigator Site, Brescia, Italy

Novartis Investigator Site, Cagliari, Italy

Novartis investigator site, Chieti, Italy

Novartis Investigator Site, Ferrara, Italy

Novartis Investigator Site, Milano, Italy

Novartis Investigator Site, Milan, Italy

Novartis Investigator Site, Orbassano, Italy

Novartis Investigator Site, Palermo, Italy

Novartis Investigator Site, Reggio Emilia, Italy

Novartis Investigator Site, Rome, Italy

Novartis Investigator Site, Sesto, Italy

Novartis Investigator Site, Siena, Italy

Novartis Investigator Site, Terni, Italy

Novartis Investigator Site, Callao, Peru

Novartis Investigator Site, Miraflores, Peru

Novartis Investigator Site, San Borja, Peru

Novartis Investigator Site, San Isidro, Peru

Novartis Investigator Site, San Martin de Porres, Peru

Novartis Investigator Site, Surco, Peru

Novartis Investigator Site, Ekaterinburg, Russian Federation

Novartis Investigator Site, Kazan, Russian Federation

Novartis Investigator Site, Moscow, Russian Federation

Novartis Investigator Site, Saint Petersburg, Russian Federation

Novartis Investigator Site, Samara, Russian Federation

Novartis Investigator Site, St Petersburg, Russian Federation

Novartis Investigator Site, Yaroslavl, Russian Federation

Novartis Investigator Site, Yekaterinburg, Russian Federation

Novartis Investigator Site, Bardejov, Slovakia

Novartis Investigator Site, Bratislava, Slovakia

Novartis Investigator Site, Kosice, Slovakia

Novartis Investigator Site, Kovice, Slovakia

Novartis Investigator Site, Spisska, Slovakia

Novartis Investigator Site, Changhua, Taiwan

Novartis Investigator Site, Kaohsiung, Taiwan

Novartis Investigator Site, Kaohusing, Taiwan

Novartis Investigator Site, Lin-ko, Taiwan

Novartis Investigator Site, Taichung, Taiwan

Novartis Investigator Site, Taipei, Taiwan

Additional Information

Starting date: November 2007
Last updated: July 22, 2011

Page last updated: August 23, 2015

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