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Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)

22 luglio 2011 aggiornato da: Novartis Pharmaceuticals

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

552

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

  • Stati Uniti
    • Alabama
      • Florence, Alabama, Stati Uniti, 35630
        • Novartis Investigator Site
      • Jasper, Alabama, Stati Uniti, 35501
        • Novartis Investigator Site
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85006
        • Novartis Investigator Site
    • Arkansas
      • Searcy, Arkansas, Stati Uniti, 72143
        • Novartis Investigator Site
    • California
      • Fullerton, California, Stati Uniti, 92835
        • Novartis Investigator Site
      • Rancho Mirage, California, Stati Uniti, 92270
        • Novartis Investigative Site
      • Riverside, California, Stati Uniti, 92506
        • Novartis Investigator Site
      • San Diego, California, Stati Uniti, 92120
        • Novartis Investigator Site
      • Stockton, California, Stati Uniti, 95207
        • Novartis Investigator Site
      • Temecula, California, Stati Uniti, 92591
        • Novartis Investigator Site
      • Walnut Creek, California, Stati Uniti, 94598
        • Novartis Investigator Site
    • Colorado
      • Wheat Ridge, Colorado, Stati Uniti, 80033
        • Novartis Investigator Site
    • Connecticut
      • Glastonbury, Connecticut, Stati Uniti, 06033
        • Novartis Investigative Site
      • Stamford, Connecticut, Stati Uniti, 06902
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, Stati Uniti, 33765
        • Novartis Investigator Site
      • Defuniak Springs, Florida, Stati Uniti, 32435
        • Novartis Investigator Site
      • Hollywood, Florida, Stati Uniti, 33021
        • Novartis Investigative Site
      • Miami, Florida, Stati Uniti, 33145
        • Novartis Investigator Site
      • Pensacola, Florida, Stati Uniti, 32503
        • Novartis Investigative Site
      • Pensacola, Florida, Stati Uniti, 32504
        • Novartis Investigative Site
      • Tamarac, Florida, Stati Uniti, 33321
        • Novartis Investigative Site
      • Tampa, Florida, Stati Uniti, 33603
        • Novartis Investigator Site
    • Illinois
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Novartis Investigator Site
    • Kentucky
      • Florence, Kentucky, Stati Uniti, 41017
        • Novartis Investigator Site
      • Madisonville, Kentucky, Stati Uniti, 42431
        • Novartis Investigator Site
    • Louisiana
      • Opelousas, Louisiana, Stati Uniti, 70570
        • Novartis Investigator Site
    • Maryland
      • Columbia, Maryland, Stati Uniti, 21044
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, Stati Uniti, 55435
        • Novartis Investigator Site
      • Fridley, Minnesota, Stati Uniti, 55432
        • Novartis Investigator Site
      • Minneapolis, Minnesota, Stati Uniti, 55402
        • Novartis Investigator Site
    • Missouri
      • Ozark, Missouri, Stati Uniti, 65721
        • Novartis Investigator Site
      • St. Louis, Missouri, Stati Uniti, 63141
        • Novartis Investigator Site
    • Nebraska
      • Bellevue, Nebraska, Stati Uniti, 68123
        • Novartis Investigator Site
      • Lincoln, Nebraska, Stati Uniti, 68510
        • Novartis Investigator Site
      • Omaha, Nebraska, Stati Uniti, 68134
        • Novartis Investigator Site
    • Nevada
      • Henderson, Nevada, Stati Uniti, 89014
        • Novartis Investigator Site
      • Las Vegas, Nevada, Stati Uniti, 89119
        • Novartis Investigator Site
      • Las Vegas, Nevada, Stati Uniti, 89183
        • Novartis Investigator Site
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Novartis Investigator Site
    • New Jersey
      • Cherry Hill, New Jersey, Stati Uniti, 08003
        • Novartis Investigative Site
    • New York
      • Bayside, New York, Stati Uniti, 11361
        • Novartis Investigative Site
      • Great Neck, New York, Stati Uniti, 11023
        • Novartis Investigative Site
      • Lake Success, New York, Stati Uniti, 11042
        • Novartis Investigative Site
      • Larchmont, New York, Stati Uniti, 10538
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28207
        • Novartis Investigative Site
      • Shelby, North Carolina, Stati Uniti, 28152
        • Novartis Investigative Site
    • Ohio
      • Cadiz, Ohio, Stati Uniti, 43907
        • Novartis Investigator Site
      • Canton, Ohio, Stati Uniti, 44718
        • Novartis Investigator Site
      • Columbus, Ohio, Stati Uniti, 43215
        • Novartis Investigator Site
      • Toledo, Ohio, Stati Uniti, 43608
        • Novartis Investigator Site
    • Oregon
      • Eugene, Oregon, Stati Uniti, 97404
        • Novartis Investigative Site
      • Medford, Oregon, Stati Uniti, 97504
        • Novartis Investigator Site
    • Pennsylvania
      • Phoenixville, Pennsylvania, Stati Uniti, 19460
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, Stati Uniti, 15243
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29407
        • Novartis Investigative Site
      • Charleston, South Carolina, Stati Uniti, 29406-7108
        • Novartis Investigative Site
      • Easley, South Carolina, Stati Uniti, 29640
        • Novartis Investigative Site
      • Greenville, South Carolina, Stati Uniti, 29615
        • Novartis Investigative Site
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Novartis Investigative Site
      • Union, South Carolina, Stati Uniti, 29379
        • Novartis Investigative Site
    • Tennessee
      • Cookeville, Tennessee, Stati Uniti, 38501
        • Novartis Investigator Site
    • Texas
      • Dickinson, Texas, Stati Uniti, 77539
        • Novartis Investigator Site
      • Ft. Worth, Texas, Stati Uniti, 76104
        • Novartis Investigator Site
      • McKinney, Texas, Stati Uniti, 75069
        • Novartis Investigator Site
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84107
        • Novartis Investigator Site
    • Virginia
      • Fredericksburg, Virginia, Stati Uniti, 22401
        • Novartis Investigative Site
      • Newport News, Virginia, Stati Uniti, 23606
        • Novartis Investigative Site
      • Richmond, Virginia, Stati Uniti, 23229
        • Novartis Investigative Site
    • Washington
      • Tacoma, Washington, Stati Uniti, 98405
        • 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:

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Indacaterol 18.75 μg
Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Droga: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Sperimentale: Indacaterol 37.5 μg
Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Droga: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Sperimentale: Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Droga: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Sperimentale: Indacaterol 150 μg
Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Indacaterol
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Droga: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Comparatore attivo: Salmeterol 50 μg
Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Salmeterol 50 μg
Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Droga: Placebo a indacaterol
Placebo a indacaterol è stato fornito in capsule riempite di polvere insieme a un dispositivo inalatore di polvere secca monodose (SDDPI).
Comparatore placebo: Placebo
Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
Droga: Placebo to salmeterol
Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
Droga: Placebo a indacaterol
Placebo a indacaterol è stato fornito in capsule riempite di polvere insieme a un dispositivo inalatore di polvere secca monodose (SDDPI).

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) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15)
Lasso di tempo: 24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose at the end of the study (Week 2 + 1 day, Day 15)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Volume espiratorio forzato minimo in 1 secondo (FEV1) 24 ore dopo la somministrazione il giorno 2
Lasso di tempo: 24 ore dopo la somministrazione il Giorno 2
Il FEV1 è stato misurato con spirometria condotta secondo standard accettati a livello internazionale. Il FEV1 minimo è stato definito come la media delle misurazioni effettuate 23 ore 10 minuti e 23 ore 45 minuti post-dose il giorno 2. L'analisi ha incluso il FEV1 basale, il FEV1 pre-dose e 10-15 minuti dopo la dose di salbutamolo/albuterolo durante lo screening e FEV1 pre-dose e 1 ora post-dose di ipratropio durante lo screening come covariate.
24 ore dopo la somministrazione il Giorno 2

Collaboratori e investigatori

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

Sponsor

Novartis Pharmaceuticals

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 marzo 2010

Completamento primario (Effettivo)

1 luglio 2010

Completamento dello studio (Effettivo)

1 luglio 2010

Date di iscrizione allo studio

Primo inviato

17 marzo 2010

Primo inviato che soddisfa i criteri di controllo qualità

17 marzo 2010

Primo Inserito (Stima)

18 marzo 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 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

  • CQAB149B2356

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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