A Phase 3 interventional study of QVA149 and fluticasone/salmeterol in Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals. Withdrawn at 31 sites in 5 countries. Per ClinicalTrials.gov, last updated 2013-11-11.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
Browse Lung Diseases, Obstructive studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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
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
QVA149 via inhaler twice a day
fluticasone/salmeterol via inhaler twice a day
Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
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
Time frame: 12 weeks
Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment
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
Time frame: Day 1 and Week 12
Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose
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.
Time frame: Day 1 and Week 12
Area under the curve (AUC) 0-4 hours for FEV1
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.
Time frame: Day 1 and Week 12
Transition Dyspnea Index (TDI) Focal Score
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.
Time frame: Week 12
Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)
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.
Time frame: Week 12
Change from baseline in daily number of puffs of rescue medication
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.
Time frame: Week 12
Daily symptoms reported by patient
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.
Time frame: Week 12
COPD assessment (CAT) test
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.
Time frame: Week 12
Safety and tolerability
All adverse events and serious adverse events (SAEs) will be reported.
Time frame: Over 12 weeks
This study is withdrawn, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals