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

February 29, 2016 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
614

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • Hungary
      • Budapest, Hungary, 1125
        • Novartis Investigative Site
      • Budapest, Hungary, 1046
        • Novartis Investigative Site
      • Gyor, Hungary, 9024
        • Novartis Investigative Site
      • Mako, Hungary, 6900
        • Novartis Investigative Site
      • Nyiregyhaza, Hungary, 4400
        • Novartis Investigative Site
      • Pecs, Hungary, 7635
        • Novartis Investigative Site
      • Szazhalombatta, Hungary, 2440
        • Novartis Investigative Site
      • Szolnok, Hungary, H-5000
        • Novartis Investigative Site
      • Torokbalint, Hungary, 2045
        • 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
  • Spain
    • Andalucia
      • Granada, Andalucia, Spain, 18014
        • Novartis Investigative Site
      • Málaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
    • Cataluña
      • Badalona, Cataluña, Spain, 08914
        • Novartis Investigative Site
      • Barcelona, Cataluña, Spain
        • Novartis Investigative Site
      • Canet de Mar, Cataluña, Spain, 08360
        • Novartis Investigative Site
      • Centelles, Cataluña, Spain, 08540
        • Novartis Investigative Site
      • Tarragona, Cataluña, Spain, 43350
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spain, 46015
        • Novartis Investigative Site
  • United States
    • Alabama
      • Vestavia, Alabama, United States, 35216
        • Novartis Investigative Site
    • California
      • Huntington Beach, California, United States, 92647
        • Novartis Investigative Site
      • Lakewood, California, United States, 90712-151
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90048
        • Novartis Investigative Site
      • Orange, California, United States, 92868
        • Novartis Investigative Site
      • Stockton, California, United States, 95207
        • Novartis Investigative Site
      • Walnut Creek, California, United States, 94598
        • Novartis Investigative Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Novartis Investigative Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Novartis Investigative Site
    • Illinois
      • Lombard, Illinois, United States, 60148
        • Novartis Investigative Site
      • O'Fallon, Illinois, United States, 62269
        • Novartis Investigative Site
      • Peoria, Illinois, United States, 61602
        • Novartis Investigative Site
    • Indiana
      • Evansville, Indiana, United States, 47712
        • Novartis Investigative Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • Novartis Investigative Site
      • Iowa City, Iowa, United States, 52240
        • Novartis Investigative Site
      • Waterloo, Iowa, United States, 50702
        • Novartis Investigative Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Novartis Investigative Site
      • Slidell, Louisiana, United States, 70458
        • Novartis Investigative Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Novartis Investigative Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Novartis Investigative Site
    • Michigan
      • Livonia, Michigan, United States, 48152
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Novartis Investigative Site
    • Mississippi
      • Jackson, Mississippi, United States, 39209
        • Novartis Investigative Site
      • Picayune, Mississippi, United States, 39466
        • Novartis Investigative Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, United States, 59804
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Novartis Investigative Site
      • Omaha, Nebraska, United States, 68131
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Novartis Investigative Site
      • Las Vegas, Nevada, United States, 89119
        • Novartis Investigative Site
    • New York
      • Rochester, New York, United States, 14618
        • Novartis Investigative Site
    • Ohio
      • Dayton, Ohio, United States, 45459
        • Novartis Investigative Site
      • Dublin, Ohio, United States, 43016
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Novartis Investigative Site
      • Oklahoma City, Oklahoma, United States, 73103
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Novartis Investigative Site
      • Medford, Oregon, United States, 97504-8741
        • Novartis Investigative Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37912
        • Novartis Investigative Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • Novartis Investigative Site
      • Ft. Worth, Texas, United States, 76104
        • Novartis Investigative Site
      • Lufkin, Texas, United States, 75904
        • Novartis Investigative Site
      • McKinney, Texas, United States, 75069
        • Novartis Investigative Site
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Novartis Investigative Site
      • Midlothian, Virginia, United States, 23114
        • Novartis Investigative Site
      • Newport News, Virginia, United States, 23606
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QVA149 dose 1
QVA149 27.5/12.5 μg capsules
Drug: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Experimental: QVA149 dose 2
QVA149 27.5/25 μg capsules
Drug: QVA149
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
Active Comparator: QAB149
QAB149 75 μg capsules
Drug: QAB149
QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
Drug: Placebo
To mimic QAB149

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events, Serious Adverse Events, and Death
Time Frame: 56 weeks
The overall rate of adverse events reported from initiation through 30 days post last dose.
56 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Premature Discontinuation of Treatment
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQVA149A2340
  • 2012-001998-93

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

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Locations

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