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

22 luglio 2011 aggiornato da: Novartis

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

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1002

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
      • Edmonton, Canada
        • Novartis Investigative 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
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigator Site
      • Bogota D.C., Colombia
        • Novartis Investigator Site
      • Medellin, Colombia
        • Novartis Investigator Site
  • Danimarca
      • Aalborg, Danimarca
        • Novartis Investigator Site
      • Arhus, Danimarca
        • Novartis Investigator Site
      • Copenhagen, Danimarca
        • Novartis Investigative Site
      • Copenhagen, Danimarca
        • Novartis Investigator Site
      • Frederikssund, Danimarca
        • Novartis Investigator Site
      • Hellerup, Danimarca
        • Novartis Investigator Site
      • Hvidovre, Danimarca
        • Novartis Investigator Site
      • Odense, Danimarca
        • Novartis Investigator Site
      • Roslev, Danimarca
        • Novartis Investigator Site
      • Silkeborg, Danimarca
        • Novartis Investigative Site
      • Soborg, Danimarca
        • Novartis Investgative Site
      • Vaerloese, Danimarca
        • Novartis Investigator Site
  • Federazione Russa
      • Ekaterinburg, Federazione Russa
        • Novartis Investigator Site
      • Kazan, Federazione Russa
        • Novartis Investigator Site
      • Moscow, Federazione Russa
        • Novartis Investigator Site
      • Saint Petersburg, Federazione Russa
        • Novartis Investigator Site
      • Samara, Federazione Russa
        • Novartis Investigator Site
      • St Petersburg, Federazione Russa
        • Novartis Investigator Site
      • Yaroslavl, Federazione Russa
        • Novartis Investigator Site
      • Yekaterinburg, Federazione Russa
        • Novartis Investigator Site
  • Finlandia
      • Hus, Finlandia
        • Novartis Investigator Site
      • Jyvaskyla, Finlandia
        • Novartis Investigator Site
      • Lahti, Finlandia
        • Novartis Investigator Site
      • Oulu, Finlandia
        • Novartis Investigator Site
      • Tampere, Finlandia
        • Novartis Investigator Site
      • Turku, Finlandia
        • Novartis Investigator Site
  • Francia
      • Ambroise, Francia
        • Novartis Investigative Site
      • Beuvry, Francia
        • Novartis Investigative Site
      • Ferolles-Attilly, Francia
        • Novartis Investgative Site
      • Nice, Francia
        • Novartis Investigator Site
  • Germania
      • Bad Segeberg, Germania
        • Novartis Investigator Site
      • Berlin, Germania
        • Novartis Investigator Site
      • Bielefeld, Germania
        • Novartis Investigator Site
      • Bochum, Germania
        • Novartis Investigator Site
      • Bonn, Germania
        • Novartis Investigator Site
      • Bruehl, Germania
        • Novartis Investigator Site
      • Cottbus, Germania
        • Novartis Investigator Site
      • Dortmund, Germania
        • Novartis Investigator Site
      • Dueren, Germania
        • Novartis Investigator Site
      • Eggenfelden, Germania
        • Novartis Investigator Site
      • Eschwege, Germania
        • Novartis Investigator Site
      • Forchheim, Germania
        • Novartis Investigator Site
      • Freudenberg, Germania
        • Novartis Investigator Site
      • Furth, Germania
        • Novartis Investigator Site
      • Gelsenkirchen, Germania
        • Novartis Investigator Site
      • Gummersbach, Germania
        • Novartis Investigator Site
      • Hagen, Germania
        • Novartis Investigator Site
      • Hannover, Germania
        • Novartis Investigator Site
      • Kassel, Germania
        • Novartis Investigator Site
      • Kempten, Germania
        • Novartis Investigator Site
      • Koeln, Germania
        • Novartis Investigator Site
      • Landsberg am Lech, Germania
        • Novartis Investigator Site
      • Langenfeld, Germania
        • Novartis Investigator Site
      • Leipzig, Germania
        • Novartis Investigator Site
      • Mainz, Germania
        • Novartis Investigator Site
      • Muenchen, Germania
        • Novartis Investigator Site
      • Munich, Germania
        • Novartis Investigator Site
      • Neuss, Germania
        • Novartis Investigator Site
      • Nuremburg, Germania
        • Novartis Investigator Site
      • Oschersleben, Germania
        • Novartis Investigator Site
      • Ruhmannsfelden, Germania
        • Novartis Investigator Site
      • Sinsheim, Germania
        • Novartis Investigator Site
      • Solingen, Germania
        • Novartis Investigator Site
      • Steinfort-borghorst, Germania
        • Novartis Investigator Site
      • Vilshofen, Germania
        • Novartis Investigator Site
      • Wallerfing, Germania
        • Novartis Investigator Site
      • Witten, Germania
        • Novartis Investigator Site
  • India
      • 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
  • Islanda
      • Reykhavik, Islanda
        • Novartis Investigator Site
  • Italia
      • Ancona, Italia
        • Novartis Investigator Site
      • Arenzano, Italia
        • Novartis Investigator Site
      • Ascoli Piceno, Italia
        • Novartis Investigative Site
      • Brescia, Italia
        • Novartis Investigator Site
      • Cagliari, Italia
        • Novartis Investigator Site
      • Chieti, Italia
        • Novartis Investigator Site
      • Ferrara, Italia
        • Novartis Investigator Site
      • Milan, Italia
        • Novartis Investigator Site
      • Milano, Italia
        • Novartis Investigator Site
      • Orbassano, Italia
        • Novartis Investigator Site
      • Palermo, Italia
        • Novartis Investigator Site
      • Reggio Emilia, Italia
        • Novartis Investigator Site
      • Rome, Italia
        • Novartis Investigator Site
      • Sesto, Italia
        • Novartis Investigator Site
      • Siena, Italia
        • Novartis Investigator Site
      • Terni, Italia
        • Novartis Investigator Site
  • Perù
      • Callao, Perù
        • Novartis Investigator Site
      • Miraflores, Perù
        • Novartis Investigator Site
      • San Borja, Perù
        • Novartis Investigator Site
      • San Isidro, Perù
        • Novartis Investigator Site
      • San Martin de Porres, Perù
        • Novartis Investigator Site
      • Surco, Perù
        • Novartis Investigator Site
  • Repubblica Ceca
      • Cvikov, Repubblica Ceca
        • Novartis Investigator Site
      • Lovosice, Repubblica Ceca
        • Novartis Investigator Site
      • Novy Jocin, Repubblica Ceca
        • Novartis Investigator Site
      • Pardubice, Repubblica Ceca
        • Novartis Investigator Site
      • Praha, Repubblica Ceca
        • Novartis Investigator Site
      • Zatec, Repubblica Ceca
        • Novartis Investigative Site
  • Slovacchia
      • Bardejov, Slovacchia
        • Novartis Investigator Site
      • Bratislava, Slovacchia
        • Novartis Investigator Site
      • Kosice, Slovacchia
        • Novartis Investigator Site
      • Kovice, Slovacchia
        • Novartis Investigator Site
      • Spisska, Slovacchia
        • Novartis Investigator Site
  • Taiwan
      • 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
        • Novartis Investigator Site
  • Ungheria
      • Budapest, Ungheria
        • Novartis Investigator Site
      • Debrechen, Ungheria
        • Novartis Investigator Site
      • Deszk, Ungheria
        • Novartis Investigator Site
      • Mosonmagyarovar, Ungheria
        • Novartis Investigator Site
      • Szekesfehervar, Ungheria
        • Novartis Investigator Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Indacaterol 150 μg
Indacaterol 150 μg once daily (o.d) inhaled
Droga: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Comparatore placebo: 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.
Droga: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Droga: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Comparatore attivo: 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.
Droga: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Droga: Salmeterol 50 μg
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Lasso di tempo: 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.
Week 12
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2007

Completamento primario (Effettivo)

1 gennaio 2009

Date di iscrizione allo studio

Primo inviato

4 dicembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

4 dicembre 2007

Primo Inserito (Stima)

5 dicembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 agosto 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2011

Ultimo verificato

1 luglio 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CQAB149B2336

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sedi

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