Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control
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
1 other identifier
interventional
1,002
15 countries
128
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedResults Posted
Study results publicly available
August 18, 2011
CompletedAugust 18, 2011
July 1, 2011
1.2 years
December 4, 2007
July 22, 2011
July 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Week 12
Secondary Outcomes (2)
St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Week 12
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Up to 26 weeks
Study Arms (3)
Indacaterol 150 μg
EXPERIMENTALIndacaterol 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.
Placebo
PLACEBO 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.
Salmeterol 50 μg
ACTIVE 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.
Interventions
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (128)
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
Medellín, Colombia
Novartis Investigator Site
Cvikov, Czechia
Novartis Investigator Site
Lovosice, Czechia
novartis Investigator site
Novy Jocin, Czechia
Novartis Investigator Site
Pardubice, Czechia
Novartis Investigator Site
Prague, Czechia
Novartis Investigative Site
Žatec, Czechia
Novartis Investigator Site
Aalborg, Denmark
Novartis Investigator Site
Aarhus, 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
Søborg, Denmark
Novartis Investigator Site
Vaerloese, Denmark
Novartis Investigator Site
Hus, Finland
Novartis Investigator Site
Jyväskylä, 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
Férolles-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
Brühl, Germany
Novartis Investigator Site
Cologne, Germany
Novartis Investigator Site
Cottbus, Germany
Novartis Investigator Site
Dortmund, Germany
Novartis Investigator Site
Düren, Germany
Novartis Investigator Site
Eggenfelden, Germany
Novartis investigator site
Eschwege, Germany
Novartis Investigator Site
Forchheim, Germany
Novartis Investigator Site
Freudenberg, Germany
Novartis Investigator Site
Fürth, Germany
Novartis Investigator Site
Gelsenkirchen, Germany
Novartis Investigator Site
Gummersbach, Germany
Novartis Investigator Site
Hagen, Germany
Novartis Investigator Site
Hanover, Germany
Novartis Investigator Site
Kassel, Germany
Novartis Investigator Site
Kempten, 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
Munich, Germany
Novartis Investigator Site
München, Germany
Novartis Investigator Site
Neuss, Germany
Novartis Investigator Site
Nuremberg, 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
Mosonmagyaróvár, Hungary
Novartis Investigator Site
Székesfehérvár, 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
Milan, 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
Sexten, 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 Martín de Porres, Peru
Novartis Investigator Site
Surco, Peru
Novartis Investigator Site
Kazan', Russia
Novartis Investigator Site
Moscow, Russia
Novartis Investigator Site
Saint Petersburg, Russia
Novartis Investigator Site
Samara, Russia
Novartis Investigator Site
Yaroslavl, Russia
Novartis Investigator Site
Yekaterinburg, Russia
Novartis Investigator Site
Bardejov, Slovakia
Novartis Investigator Site
Bratislava, Slovakia
Novartis Investigator Site
Košice, Slovakia
Novartis Investigator Site
Kovice, Slovakia
Novartis Investigator Site
Spišská Nová Ves, Slovakia
Novartis Investigator Site
Changhua, Taiwan
Novartis Investigator Site
Kaohsiung City, Taiwan
Novartis Investigator Site
Kaohusing, Taiwan
Novartis Investigator Site
Lin-ko, Taiwan
Novartis Investigator Site
Taichung, Taiwan
Novartis Investigator Site
Taipei, Taiwan
Related Publications (3)
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.
PMID: 22158330DERIVEDJones 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.
PMID: 21397482DERIVEDWorth 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.
PMID: 21227674DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY CHAIR
Novartis Pharma AG
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 5, 2007
Study Start
November 1, 2007
Primary Completion
January 1, 2009
Last Updated
August 18, 2011
Results First Posted
August 18, 2011
Record last verified: 2011-07