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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

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ClinicalTrials.gov Identifier: NCT01682863
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE September 7, 2012
First Posted Date  ICMJE September 11, 2012
Results First Submitted Date  ICMJE June 22, 2015
Results First Posted Date  ICMJE March 30, 2016
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
overall adverse event reporting rate [ Time Frame: 56 weeks ]
The overall rate of adverse events reported from initiation through 30 days post last dose.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • 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
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
  • Vital signs, ECG and laboratory evaluations [ Time Frame: 52 weeks ]
  • Time to discontinuation [ Time Frame: 52 weeks ]
  • FEV1 pre-dose [ Time Frame: 52 weeks ]
  • FEV1 and FVC at all post-baseline time points [ Time Frame: 52 weeks ]
  • Time to first exacerbation [ Time Frame: 52 weeks ]
  • Symptoms reported over the 52 week period [ Time Frame: 52 weeks ]
  • Number of puffs of rescue medication over the 52 week period [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: QVA149
    QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
  • 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
Study Arms  ICMJE
  • Experimental: QVA149 dose 1
    QVA149 27.5/12.5 μg capsules
    Intervention: Drug: QVA149
  • Experimental: QVA149 dose 2
    QVA149 27.5/25 μg capsules
    Intervention: Drug: QVA149
  • Active Comparator: QAB149
    QAB149 75 μg capsules
    Interventions:
    • Drug: QAB149
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
614
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2012)
600
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Finland,   Hungary,   Puerto Rico,   Romania,   Spain,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT01682863
Other Study ID Numbers  ICMJE CQVA149A2340
2012-001998-93
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP