Clinical trial NCT00567996: Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 1002
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
timeFrame: Week 12
Secondary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
timeFrame: Week 12
measure: Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
timeFrame: Up to 26 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Novartis Investigative Site
city: Edmonton
country: Canada
facility: Novartis Investigator Site
city: London
country: Canada
facility: Novartis Investigator Site
city: Mirabel
country: Canada
facility: Novartis Investigator Site
city: Montreal
country: Canada
facility: Novartis Investigator Site
city: Toronto
country: Canada
facility: Novartis Investigator Site
city: Barranquilla
country: Colombia
facility: Novartis Investigator site
city: Bogota D.C.
country: Colombia
facility: Novartis Investigator Site
city: Medellin
country: Colombia
facility: Novartis Investigator Site
city: Cvikov
country: Czech Republic
facility: Novartis Investigator Site
city: Lovosice
country: Czech Republic
facility: Novartis Investigator Site
city: Novy Jocin
country: Czech Republic
facility: novartis Investigator site
city: Pardubice
country: Czech Republic
facility: Novartis Investigator Site
city: Praha
country: Czech Republic
facility: Novartis Investigator Site
city: Zatec
country: Czech Republic
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigator Site
city: Arhus
country: Denmark
facility: Novartis Investigator Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigator Site
city: Frederikssund
country: Denmark
facility: Novartis Investigator Site
city: Hellerup
country: Denmark
facility: Novartis investigator site
city: Hvidovre
country: Denmark
facility: Novartis Investigator site
city: Odense
country: Denmark
facility: Novartis investigator site
city: Roslev
country: Denmark
facility: Novartis Investigator Site
city: Silkeborg
country: Denmark
facility: Novartis Investigative Site
city: Soborg
country: Denmark
facility: Novartis Investgative Site
city: Vaerloese
country: Denmark
facility: Novartis Investigator Site
city: Hus
country: Finland
facility: Novartis Investigator Site
city: Jyvaskyla
country: Finland
facility: Novartis Investigator Site
city: Lahti
country: Finland
facility: Novartis Investigator Site
city: Oulu
country: Finland
facility: Novartis Investigator Site
city: Tampere
country: Finland
facility: Novartis Investigator Site
city: Turku
country: Finland
facility: Novartis Investigator Site
city: Ambroise
country: France
facility: Novartis Investigative Site
city: Beuvry
country: France
facility: Novartis Investigative Site
city: Ferolles-Attilly
country: France
facility: Novartis Investgative Site
city: Nice
country: France
facility: Novartis Investigator Site
city: Bad Segeberg
country: Germany
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Bielefeld
country: Germany
facility: Novartis Investigator Site
city: Bochum
country: Germany
facility: Novartis Investigator Site
city: Bonn
country: Germany
facility: Novartis Investigator Site
city: Bruehl
country: Germany
facility: Novartis Investigator Site
city: Cottbus
country: Germany
facility: Novartis Investigator Site
city: Dortmund
country: Germany
facility: Novartis Investigator Site
city: Dueren
country: Germany
facility: Novartis Investigator Site
city: Eggenfelden
country: Germany
facility: Novartis Investigator Site
city: Eschwege
country: Germany
facility: Novartis investigator site
city: Forchheim
country: Germany
facility: Novartis Investigator Site
city: Freudenberg
country: Germany
facility: Novartis Investigator Site
city: Furth
country: Germany
facility: Novartis Investigator Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigator Site
city: Gummersbach
country: Germany
facility: Novartis Investigator Site
city: Hagen
country: Germany
facility: Novartis Investigator Site
city: Hannover
country: Germany
facility: Novartis Investigator Site
city: Kassel
country: Germany
facility: Novartis Investigator Site
city: Kempten
country: Germany
facility: Novartis Investigator Site
city: Koeln
country: Germany
facility: Novartis Investigator Site
city: Landsberg am Lech
country: Germany
facility: Novartis Investigator Site
city: Langenfeld
country: Germany
facility: Novartis Investigator Site
city: Leipzig
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Muenchen
country: Germany
facility: Novartis Investigator Site
city: Munich
country: Germany
facility: Novartis Investigator Site
city: Neuss
country: Germany
facility: Novartis Investigator Site
city: Nuremburg
country: Germany
facility: Novartis Investigator Site
city: Oschersleben
country: Germany
facility: Novartis Investigator Site
city: Ruhmannsfelden
country: Germany
facility: Novartis Investigator Site
city: Sinsheim
country: Germany
facility: Novartis Investigator site
city: Solingen
country: Germany
facility: Novartis Investigator Site
city: Steinfort-borghorst
country: Germany
facility: Novartis Investigator Site
city: Vilshofen
country: Germany
facility: Novartis Investigator Site
city: Wallerfing
country: Germany
facility: Novartis Investigator Site
city: Witten
country: Germany
facility: Novartis Investigator Site
city: Budapest
country: Hungary
facility: Novartis Investigator Site
city: Debrechen
country: Hungary
facility: Novartis investigator site
city: Deszk
country: Hungary
facility: Novartis Investigator Site
city: Mosonmagyarovar
country: Hungary
facility: Novartis Investigator Site
city: Szekesfehervar
country: Hungary
facility: Novartis Investigator Site
city: Reykhavik
country: Iceland
facility: Novartis investigator site
city: Chennai
country: India
facility: Novartis Investigator Site
city: Coimbatore
country: India
facility: Novartis Investigator Site
city: Goa
country: India
facility: Novartis Investigator Site
city: Hyderabad
country: India
facility: Novartis Investigator Site
city: Jaipur
country: India
facility: Novartis Investigator Site
city: Kerala
country: India
facility: Novartis Investigator Site
city: Mangalore
country: India
facility: Novartis Investigator Site
city: Mumbai
country: India
facility: Novartis Investigator Site
city: Vellore
country: India
facility: Novartis Investigator Site
city: Ancona
country: Italy
facility: Novartis Investigator Site
city: Arenzano
country: Italy
facility: Novartis Investigator Site
city: Ascoli Piceno
country: Italy
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigator Site
city: Cagliari
country: Italy
facility: Novartis Investigator Site
city: Chieti
country: Italy
facility: Novartis investigator site
city: Ferrara
country: Italy
facility: Novartis Investigator Site
city: Milano
country: Italy
facility: Novartis Investigator Site
city: Milan
country: Italy
facility: Novartis Investigator Site
city: Orbassano
country: Italy
facility: Novartis Investigator Site
city: Palermo
country: Italy
facility: Novartis Investigator Site
city: Reggio Emilia
country: Italy
facility: Novartis Investigator Site
city: Rome
country: Italy
facility: Novartis Investigator Site
city: Sesto
country: Italy
facility: Novartis Investigator Site
city: Siena
country: Italy
facility: Novartis Investigator Site
city: Terni
country: Italy
facility: Novartis Investigator Site
city: Callao
country: Peru
facility: Novartis Investigator Site
city: Miraflores
country: Peru
facility: Novartis Investigator Site
city: San Borja
country: Peru
facility: Novartis Investigator Site
city: San Isidro
country: Peru
facility: Novartis Investigator Site
city: San Martin de Porres
country: Peru
facility: Novartis Investigator Site
city: Surco
country: Peru
facility: Novartis Investigator Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigator Site
city: Kazan
country: Russian Federation
facility: Novartis Investigator Site
city: Moscow
country: Russian Federation
facility: Novartis Investigator Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigator Site
city: Samara
country: Russian Federation
facility: Novartis Investigator Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigator Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigator Site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigator Site
city: Bardejov
country: Slovakia
facility: Novartis Investigator Site
city: Bratislava
country: Slovakia
facility: Novartis Investigator Site
city: Kosice
country: Slovakia
facility: Novartis Investigator Site
city: Kovice
country: Slovakia
facility: Novartis Investigator Site
city: Spisska
country: Slovakia
facility: Novartis Investigator Site
city: Changhua
country: Taiwan
facility: Novartis Investigator Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigator Site
city: Kaohusing
country: Taiwan
facility: Novartis Investigator Site
city: Lin-ko
country: Taiwan
facility: Novartis Investigator Site
city: Taichung
country: Taiwan
facility: Novartis Investigator Site
city: Taipei
country: Taiwan
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.