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A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

29. februar 2016 oppdatert av: Novartis Pharmaceuticals
This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

614

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4002
        • Novartis Investigative Site
      • Ruse, Bulgaria, 7002
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
      • Varna, Bulgaria, 9010
        • Novartis Investigative Site
  • Finland
      • HUS, Finland, 00029
        • Novartis Investigative Site
      • Helsinki, Finland, 00029
        • Novartis Investigative Site
      • Pori, Finland, FIN-28500
        • Novartis Investigative Site
      • Turku, Finland, 20521
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Vestavia, Alabama, Forente stater, 35216
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, Forente stater, 92647
        • Novartis Investigative Site
      • Lakewood, California, Forente stater, 90712-151
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90048
        • Novartis Investigative Site
      • Orange, California, Forente stater, 92868
        • Novartis Investigative Site
      • Stockton, California, Forente stater, 95207
        • Novartis Investigative Site
      • Walnut Creek, California, Forente stater, 94598
        • Novartis Investigative Site
    • Colorado
      • Boulder, Colorado, Forente stater, 80304
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • Novartis Investigative Site
    • Illinois
      • Lombard, Illinois, Forente stater, 60148
        • Novartis Investigative Site
      • O'Fallon, Illinois, Forente stater, 62269
        • Novartis Investigative Site
      • Peoria, Illinois, Forente stater, 61602
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, Forente stater, 47712
        • Novartis Investigative Site
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Novartis Investigative Site
      • Iowa City, Iowa, Forente stater, 52240
        • Novartis Investigative Site
      • Waterloo, Iowa, Forente stater, 50702
        • Novartis Investigative Site
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42101
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70115
        • Novartis Investigative Site
      • Slidell, Louisiana, Forente stater, 70458
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Novartis Investigative Site
    • Michigan
      • Livonia, Michigan, Forente stater, 48152
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, Forente stater, 39209
        • Novartis Investigative Site
      • Picayune, Mississippi, Forente stater, 39466
        • Novartis Investigative Site
    • Missouri
      • St. Charles, Missouri, Forente stater, 63301
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, Forente stater, 59804
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68506
        • Novartis Investigative Site
      • Omaha, Nebraska, Forente stater, 68131
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89014
        • Novartis Investigative Site
      • Las Vegas, Nevada, Forente stater, 89119
        • Novartis Investigative Site
    • New York
      • Rochester, New York, Forente stater, 14618
        • Novartis Investigative Site
    • Ohio
      • Dayton, Ohio, Forente stater, 45459
        • Novartis Investigative Site
      • Dublin, Ohio, Forente stater, 43016
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Forente stater, 97404
        • Novartis Investigative Site
      • Medford, Oregon, Forente stater, 97504-8741
        • Novartis Investigative Site
    • South Carolina
      • Spartanburg, South Carolina, Forente stater, 29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37912
        • Novartis Investigative Site
    • Texas
      • Corsicana, Texas, Forente stater, 75110
        • Novartis Investigative Site
      • Ft. Worth, Texas, Forente stater, 76104
        • Novartis Investigative Site
      • Lufkin, Texas, Forente stater, 75904
        • Novartis Investigative Site
      • McKinney, Texas, Forente stater, 75069
        • Novartis Investigative Site
    • Virginia
      • Abingdon, Virginia, Forente stater, 24210
        • Novartis Investigative Site
      • Midlothian, Virginia, Forente stater, 23114
        • Novartis Investigative Site
      • Newport News, Virginia, Forente stater, 23606
        • Novartis Investigative Site
  • Puerto Rico
      • Barceloneta, Puerto Rico, 00617
        • Novartis Investigative Site
      • San Juan, Puerto Rico, 00909
        • Novartis Investigative Site
      • San Juan, Puerto Rico, 00918
        • Novartis Investigative Site
  • Romania
      • Brasov, Romania, 500281
        • Novartis Investigative Site
      • Bucharest, Romania, 060011
        • Novartis Investigative Site
      • Bucuresti, Romania, 50554
        • Novartis Investigative Site
      • Cluj-Napoca, Romania, 400371
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Romania, 10457
        • Novartis Investigative Site
      • Bucharest, District 1, Romania, 11475
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Romania, 030303
        • Novartis Investigative Site
      • Bucharest, District 3, Romania, 030317
        • Novartis Investigative Site
    • Jud. Constanta
      • Constanta, Jud. Constanta, Romania, 900002
        • Novartis Investigative Site
    • Jud. Iasi
      • Iasi, Jud. Iasi, Romania, 700115
        • Novartis Investigative Site
  • Spania
    • Andalucia
      • Granada, Andalucia, Spania, 18014
        • Novartis Investigative Site
      • Málaga, Andalucia, Spania, 29010
        • Novartis Investigative Site
    • Cataluña
      • Badalona, Cataluña, Spania, 08914
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spania
        • Novartis Investigative Site
      • Canet de Mar, Cataluña, Spania, 08360
        • Novartis Investigative Site
      • Centelles, Cataluña, Spania, 08540
        • Novartis Investigative Site
      • Tarragona, Cataluña, Spania, 43350
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spania, 46015
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1125
        • Novartis Investigative Site
      • Budapest, Ungarn, 1046
        • Novartis Investigative Site
      • Gyor, Ungarn, 9024
        • Novartis Investigative Site
      • Mako, Ungarn, 6900
        • Novartis Investigative Site
      • Nyiregyhaza, Ungarn, 4400
        • Novartis Investigative Site
      • Pecs, Ungarn, 7635
        • Novartis Investigative Site
      • Szazhalombatta, Ungarn, 2440
        • Novartis Investigative Site
      • Szolnok, Ungarn, H-5000
        • Novartis Investigative Site
      • Torokbalint, Ungarn, 2045
        • Novartis Investigative Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female adults aged ≥40 years
  • Patients with stable COPD according to GOLD strategy (GOLD 2011).
  • Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
  • Current or ex-smokers who have a smoking history of at least 10 pack years.
  • Patients with an mMRC ≥ grade 2

Exclusion Criteria:

  • History of long QT syndrome or prolonged QTc
  • Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
  • Patients with Type I or uncontrolled Type II diabetes
  • Patients with a history of asthma or have concomitant pulmonary disease
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
  • Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
  • Other protocol defined inclusion/exclusion criteria may apply

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: QVA149 dose 1
QVA149 27.5/12.5 μg capsules
Legemiddel: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Eksperimentell: QVA149 dose 2
QVA149 27.5/25 μg capsules
Legemiddel: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Aktiv komparator: QAB149
QAB149 75 μg capsules
Legemiddel: QAB149
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Legemiddel: Placebo
To mimic QAB149

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Tidsramme: 56 weeks
The overall rate of adverse events reported from initiation through 30 days post last dose.
56 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Premature Discontinuation of Treatment
Tidsramme: 56 weeks
methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl
56 weeks
Change From Baseline in Pre-dose Trough FEV1
Tidsramme: Day 29, 57,, 85, 141, 197, 253, 309 and 365
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Day 29, 57,, 85, 141, 197, 253, 309 and 365
Change From Baseline in 1 Hour Post-dose FEV1 Measurements
Tidsramme: Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.
Day 1, 29, 57, 85, 141, 197, 253, 309, and 365
Change From Baseline in FVC Measurement at All Post-baseline Time Points
Tidsramme: Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Pulmonary function assessments were performed using centralized spirometry according to international standards.
Day1, 29, 57, 85, 141, 197, 253, 309, and 365
Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation
Tidsramme: 52 weeks
Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)
52 weeks
Change From Baseline in Mean Total Daily Symptom Scores
Tidsramme: 52 weeks
The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.
52 weeks
Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period
Tidsramme: 52 weeks
Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.
52 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2012

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først innsendt

7. september 2012

Først innsendt som oppfylte QC-kriteriene

7. september 2012

Først lagt ut (Anslag)

11. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CQVA149A2340
  • 2012-001998-93

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