A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD

November 8, 2013 updated by: Novartis Pharmaceuticals

A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation

Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1115AAB
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Buenos Aires, Argentina, 1425
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Novartis Investigative Site
  • Belgium
      • Antwerpen, Belgium, 2060
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1000
        • Novartis Investigative Site
      • Genk, Belgium, 3600
        • Novartis Investigative Site
      • Gilly, Belgium, 6060
        • Novartis Investigative Site
      • Hasselt, Belgium, 3500
        • Novartis Investigative Site
      • Jambes, Belgium, 5100
        • Novartis Investigative Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Florida Blanca, Colombia
        • Novartis Investigative Site
      • Medellín, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Cvikov, Czech Republic, 471 54
        • Novartis Investigative Site
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Novartis Investigative Site
      • Karlovy Vary, Czech Republic, 360 66
        • Novartis Investigative Site
      • Kurim, Czech Republic, 664 34
        • Novartis Investigative Site
      • Pardubice, Czech Republic, 530 09
        • Novartis Investigative Site
      • Teplice, Czech Republic, 415 01
        • Novartis Investigative Site
    • CZE
      • Kyjov, CZE, Czech Republic, 697 70
        • Novartis Investigative Site
  • India
      • Karamsad, India, 388225
        • Novartis Investigative Site
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522 001
        • Novartis Investigative Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 008
        • Novartis Investigative Site
    • Haryana
      • Faridabad, Haryana, India, 121 001
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 002
        • Novartis Investigative Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 400 012
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411004
        • Novartis Investigative Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • 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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year smoking history, patients with a mMRC grade 2 or greater Exclusion Criteria: - prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments not allowed in the study, other concomitant pulmonary diseases.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QVA149
QVA149 study medication kit will contain blister strips and a unique inhaler. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Drug: QVA149
QVA149 via inhaler twice a day
Active Comparator: fluticasone/salmeterol
Fluticasone/salmeterol study medication kit will contain an inhaler in the manufacturer's device. Patients will be instructed to inhale their medication twice a day for 12 weeks.
Drug: fluticasone/salmeterol
fluticasone/salmeterol via inhaler twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
Time Frame: 12 weeks
Area under the curve (AUC) 0-12 hours for Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition Dyspnea Index (TDI) Focal Score
Time Frame: Week 12
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline; negative scores indicate deterioration. A TDI focal score of 1 unit is considered to be a minimal clinically important difference (MCID) from baseline.
Week 12
Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)
Time Frame: Week 12
SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from baseline in total score will be assessed.
Week 12
Change from baseline in daily number of puffs of rescue medication
Time Frame: Week 12
Number of puffs of rescue medication in previous 12 hours is recorded in Patient Diary twice daily. The total number of puffs of rescue medication per day (daily use) over the active treatment period will be used to derive the mean daily number of puffs of rescue medication taken by the patient.
Week 12
Daily symptoms reported by patient
Time Frame: Week 12
Patient's daily symptoms will be recorded twice daily using a patient diary. Mean daily total symptom score, mean morning and evening symptom score for each patient will be calculated over the 12 week study period.
Week 12
COPD assessment (CAT) test
Time Frame: Week 12
COPD assessment test (CAT) contains 8 questions regarding patient symptoms. Patient will complete questions using a 6 point scale and total score out of a possible score of 40 will be summed and reported.
Week 12
Safety and tolerability
Time Frame: Over 12 weeks
All adverse events and serious adverse events (SAEs) will be reported.
Over 12 weeks
Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose
Time Frame: Day 1 and Week 12
Spirometry testing conducted accorded to internationally accepted standards. Peak FEV1 defined as the maximum FEV1 during the first 4 hours post dosing. The Peak FEV1 will be defined as the mean from repeat measurements at Day 1 and week 12.
Day 1 and Week 12
Area under the curve (AUC) 0-4 hours for FEV1
Time Frame: Day 1 and Week 12
Area under the curve (AUC) 0-4 hours for Forced Expiratory Volume in 1 second (FEV1) at Day 1 and week 12. AUC will be calculated using the trapezoidal rule and standardized with respect to length of time from the first 5 minute to the last measurement at 12 hours.
Day 1 and Week 12
Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment
Time Frame: Day 1 and Week 12
Spiromtery testing conducted according to internationally accepted standards. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough FEV1 will be will be defined as the mean from repeat measurements at Day 1 and week 12
Day 1 and Week 12

Collaborators and Investigators

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

Sponsor

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

December 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQVA149A2328

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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