- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834885
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Withdrawn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
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Feldkirch, Austria, 6800
- Novartis Investigative Site
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Grieskirchen, Austria, 4710
- Novartis Investigative Site
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Hallein, Austria, 5400
- Novartis Investigative Site
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Linz, Austria, 4020
- Novartis Investigative Site
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Thalheim bei Wels, Austria, 4600
- Novartis Investigative Site
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Wels, Austria, 4600
- Novartis Investigative Site
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Aschaffenburg, Germany, 63739
- Novartis Investigative Site
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Bad Woerishofen, Germany, 86825
- Novartis Investigative Site
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Berlin, Germany, 12203
- Novartis Investigative Site
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Berlin, Germany, 12687
- Novartis Investigative Site
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Berlin, Germany, 10717
- Novartis Investigative Site
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Berlin, Germany, 10117
- Novartis Investigative Site
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Berlin, Germany, 13156
- Novartis Investigative Site
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Berlin, Germany, 10789
- Novartis Investigative Site
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Berlin, Germany, 10119
- Novartis Investigative Site
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Dresden, Germany, 01307
- Novartis Investigative Site
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Frankfurt, Germany, 60596
- Novartis Investigative Site
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Frankfurt, Germany, 60389
- Novartis Investigative Site
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Grosshansdorf, Germany, 22947
- Novartis Investigative Site
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Hamburg, Germany, 20354
- Novartis Investigative Site
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Hamburg, Germany, 20253
- Novartis Investigative Site
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Hamburg, Germany, 22335
- Novartis Investigative Site
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Hannover, Germany, 30317
- Novartis Investigative Site
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Leipzig, Germany, 04207
- Novartis Investigative Site
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Leipzig, Germany, 04357
- Novartis Investigative Site
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Lübeck, Germany, 23552
- Novartis Investigative Site
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Münster, Germany, 48145
- Novartis Investigative Site
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Potsdam, Germany, 14467
- Novartis Investigative Site
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Rheine, Germany, 48431
- Novartis Investigative Site
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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.
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QVA149 via inhaler twice a day
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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.
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fluticasone/slameterol via inhaler twice a day
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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
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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.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment
Time Frame: Day 1 and Week 12
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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.
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Day 1 and Week 12
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Transition Dyspnea Index (TDI) Focal Score
Time Frame: Week 12
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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.
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Week 12
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Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)
Time Frame: Week 12
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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.
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Week 12
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Change from baseline in daily number of puffs of rescue medication
Time Frame: Week 12
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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.
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Week 12
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Daily symptoms reported by patient
Time Frame: Week 12
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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.
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Week 12
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COPD assessment (CAT) test
Time Frame: Week 12
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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.
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Week 12
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Safety and tolerability
Time Frame: Over 12 weeks
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All adverse events and serious adverse events (SAEs) will be reported.
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Over 12 weeks
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Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose
Time Frame: Day 1 and Week 12
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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.
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Day 1 and Week 12
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Area under the curve (AUC) 0-4 hours for FEV1
Time Frame: Day 1 and Week 12
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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.
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Day 1 and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
April 15, 2013
First Posted (Estimate)
April 18, 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
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Fluticasone
- Salmeterol Xinafoate
- Fluticasone-Salmeterol Drug Combination
Other Study ID Numbers
- CQVA149A2327
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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