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
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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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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Medellin, Colombia
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Aalborg, Danmark
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Arhus, Danmark
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Copenhagen, Danmark
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Copenhagen, Danmark
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Frederikssund, Danmark
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Hellerup, Danmark
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Hvidovre, Danmark
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Odense, Danmark
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Roslev, Danmark
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Silkeborg, Danmark
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Soborg, Danmark
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Vaerloese, Danmark
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Ekaterinburg, Den russiske føderasjonen
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Kazan, Den russiske føderasjonen
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Moscow, Den russiske føderasjonen
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Saint Petersburg, Den russiske føderasjonen
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Samara, Den russiske føderasjonen
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St Petersburg, Den russiske føderasjonen
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Yaroslavl, Den russiske føderasjonen
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Yekaterinburg, Den russiske føderasjonen
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Hus, Finland
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Jyvaskyla, 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, Frankrike
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Beuvry, Frankrike
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Ferolles-Attilly, Frankrike
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Nice, Frankrike
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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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Reykhavik, Island
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Ancona, Italia
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Arenzano, Italia
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Ascoli Piceno, Italia
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Brescia, Italia
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Cagliari, Italia
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Chieti, Italia
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Ferrara, Italia
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Milan, Italia
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Milano, Italia
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Orbassano, Italia
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Palermo, Italia
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Reggio Emilia, Italia
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Rome, Italia
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Sesto, Italia
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Siena, Italia
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Terni, Italia
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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 Martin de Porres, Peru
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Surco, Peru
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Bardejov, Slovakia
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Bratislava, Slovakia
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Kosice, Slovakia
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Kovice, Slovakia
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Spisska, Slovakia
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Changhua, Taiwan
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Kaohsiung, 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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Cvikov, Tsjekkisk Republikk
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Lovosice, Tsjekkisk Republikk
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Novy Jocin, Tsjekkisk Republikk
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Pardubice, Tsjekkisk Republikk
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Praha, Tsjekkisk Republikk
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Zatec, Tsjekkisk Republikk
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Bad Segeberg, Tyskland
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Berlin, Tyskland
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Bielefeld, Tyskland
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Bochum, Tyskland
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Bonn, Tyskland
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Bruehl, Tyskland
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Cottbus, Tyskland
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Dortmund, Tyskland
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Dueren, Tyskland
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Eggenfelden, Tyskland
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Eschwege, Tyskland
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Forchheim, Tyskland
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Freudenberg, Tyskland
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Furth, Tyskland
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Gelsenkirchen, Tyskland
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Gummersbach, Tyskland
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Hagen, Tyskland
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Hannover, Tyskland
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Kassel, Tyskland
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Kempten, Tyskland
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Koeln, Tyskland
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Landsberg am Lech, Tyskland
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Langenfeld, Tyskland
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Leipzig, Tyskland
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Mainz, Tyskland
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Muenchen, Tyskland
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Munich, Tyskland
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Neuss, Tyskland
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Nuremburg, Tyskland
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Oschersleben, Tyskland
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Ruhmannsfelden, Tyskland
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Sinsheim, Tyskland
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Solingen, Tyskland
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Steinfort-borghorst, Tyskland
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Vilshofen, Tyskland
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Wallerfing, Tyskland
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Witten, Tyskland
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Budapest, Ungarn
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Debrechen, Ungarn
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Deszk, Ungarn
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Mosonmagyarovar, Ungarn
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Szekesfehervar, Ungarn
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
Indacaterol 150 μg once daily (o.d) inhaled
Placebo to salmeterol delivered via a proprietary dry powder inhaler
|
|
Placebo komparator: 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. |
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Placebo to Indacaterol inhaled via SDDPI.
|
|
Aktiv komparator: 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. |
Placebo to Indacaterol inhaled via SDDPI.
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Tidsramme: Week 12
|
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
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Tidsramme: Week 12
|
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.
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Week 12
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Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Tidsramme: Up to 26 weeks
|
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.
|
Up to 26 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Lungesykdommer
- Lungesykdommer, obstruktiv
- Lungesykdom, kronisk obstruktiv
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Adrenerge agonister
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Adrenerge beta-2-reseptoragonister
- Adrenerge beta-agonister
- Salmeterol Xinafoate
Andre studie-ID-numre
Andre studie-ID-numre
- CQAB149B2336
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