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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

614

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgarien, 4002
        • Novartis Investigative Site
      • Ruse, Bulgarien, 7002
        • Novartis Investigative Site
      • Sofia, Bulgarien, 1431
        • Novartis Investigative Site
      • Varna, Bulgarien, 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
  • Forenede Stater
    • Alabama
      • Vestavia, Alabama, Forenede Stater, 35216
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, Forenede Stater, 92647
        • Novartis Investigative Site
      • Lakewood, California, Forenede Stater, 90712-151
        • Novartis Investigative Site
      • Los Angeles, California, Forenede Stater, 90048
        • Novartis Investigative Site
      • Orange, California, Forenede Stater, 92868
        • Novartis Investigative Site
      • Stockton, California, Forenede Stater, 95207
        • Novartis Investigative Site
      • Walnut Creek, California, Forenede Stater, 94598
        • Novartis Investigative Site
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80304
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96814
        • Novartis Investigative Site
    • Illinois
      • Lombard, Illinois, Forenede Stater, 60148
        • Novartis Investigative Site
      • O'Fallon, Illinois, Forenede Stater, 62269
        • Novartis Investigative Site
      • Peoria, Illinois, Forenede Stater, 61602
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47712
        • Novartis Investigative Site
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • Novartis Investigative Site
      • Iowa City, Iowa, Forenede Stater, 52240
        • Novartis Investigative Site
      • Waterloo, Iowa, Forenede Stater, 50702
        • Novartis Investigative Site
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70115
        • Novartis Investigative Site
      • Slidell, Louisiana, Forenede Stater, 70458
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, Forenede Stater, 04401
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21224
        • Novartis Investigative Site
    • Michigan
      • Livonia, Michigan, Forenede Stater, 48152
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39209
        • Novartis Investigative Site
      • Picayune, Mississippi, Forenede Stater, 39466
        • Novartis Investigative Site
    • Missouri
      • St. Charles, Missouri, Forenede Stater, 63301
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, Forenede Stater, 59804
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Novartis Investigative Site
      • Omaha, Nebraska, Forenede Stater, 68131
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Novartis Investigative Site
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Novartis Investigative Site
    • New York
      • Rochester, New York, Forenede Stater, 14618
        • Novartis Investigative Site
    • Ohio
      • Dayton, Ohio, Forenede Stater, 45459
        • Novartis Investigative Site
      • Dublin, Ohio, Forenede Stater, 43016
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • Novartis Investigative Site
      • Medford, Oregon, Forenede Stater, 97504-8741
        • Novartis Investigative Site
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37912
        • Novartis Investigative Site
    • Texas
      • Corsicana, Texas, Forenede Stater, 75110
        • Novartis Investigative Site
      • Ft. Worth, Texas, Forenede Stater, 76104
        • Novartis Investigative Site
      • Lufkin, Texas, Forenede Stater, 75904
        • Novartis Investigative Site
      • McKinney, Texas, Forenede Stater, 75069
        • Novartis Investigative Site
    • Virginia
      • Abingdon, Virginia, Forenede Stater, 24210
        • Novartis Investigative Site
      • Midlothian, Virginia, Forenede Stater, 23114
        • Novartis Investigative Site
      • Newport News, Virginia, Forenede 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
  • Rumænien
      • Brasov, Rumænien, 500281
        • Novartis Investigative Site
      • Bucharest, Rumænien, 060011
        • Novartis Investigative Site
      • Bucuresti, Rumænien, 50554
        • Novartis Investigative Site
      • Cluj-Napoca, Rumænien, 400371
        • Novartis Investigative Site
    • District 1
      • Bucharest, District 1, Rumænien, 10457
        • Novartis Investigative Site
      • Bucharest, District 1, Rumænien, 11475
        • Novartis Investigative Site
    • District 3
      • Bucharest, District 3, Rumænien, 030303
        • Novartis Investigative Site
      • Bucharest, District 3, Rumænien, 030317
        • Novartis Investigative Site
    • Jud. Constanta
      • Constanta, Jud. Constanta, Rumænien, 900002
        • Novartis Investigative Site
    • Jud. Iasi
      • Iasi, Jud. Iasi, Rumænien, 700115
        • Novartis Investigative Site
  • Spanien
    • Andalucia
      • Granada, Andalucia, Spanien, 18014
        • Novartis Investigative Site
      • Málaga, Andalucia, Spanien, 29010
        • Novartis Investigative Site
    • Cataluña
      • Badalona, Cataluña, Spanien, 08914
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spanien
        • Novartis Investigative Site
      • Canet de Mar, Cataluña, Spanien, 08360
        • Novartis Investigative Site
      • Centelles, Cataluña, Spanien, 08540
        • Novartis Investigative Site
      • Tarragona, Cataluña, Spanien, 43350
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spanien, 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: QVA149 dose 1
QVA149 27.5/12.5 μg capsules
Medicin: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Eksperimentel: QVA149 dose 2
QVA149 27.5/25 μg capsules
Medicin: 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
Medicin: QAB149
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Medicin: Placebo
To mimic QAB149

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2012

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

7. september 2012

Først indsendt, der opfyldte QC-kriterier

7. september 2012

Først opslået (Skøn)

11. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQVA149A2340
  • 2012-001998-93

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med QVA149

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner