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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01834885
Other study ID # CQVA149A2327
Secondary ID
Status Withdrawn
Phase Phase 3
First received April 15, 2013
Last updated November 8, 2013
Start date December 2013
Est. completion date September 2014

Study information

Verified date November 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
QVA149
QVA149 via inhaler twice a day
fluticasone/salmeterol
fluticasone/slameterol via inhaler twice a day

Locations

Country Name City State
Austria Novartis Investigative Site Feldkirch
Austria Novartis Investigative Site Grieskirchen
Austria Novartis Investigative Site Hallein
Austria Novartis Investigative Site Linz
Austria Novartis Investigative Site Thalheim bei Wels
Austria Novartis Investigative Site Wels
Germany Novartis Investigative Site Aschaffenburg
Germany Novartis Investigative Site Bad Woerishofen
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Frankfurt
Germany Novartis Investigative Site Grosshansdorf
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Lübeck
Germany Novartis Investigative Site Münster
Germany Novartis Investigative Site Potsdam
Germany Novartis Investigative Site Rheine

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks No
Secondary 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. Day 1 and Week 12 No
Secondary 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. Week 12 No
Secondary 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. Week 12 No
Secondary 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. Week 12 No
Secondary 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. Week 12 No
Secondary 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. Week 12 No
Secondary Safety and tolerability All adverse events and serious adverse events (SAEs) will be reported. Over 12 weeks Yes
Secondary 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. Day 1 and Week 12 No
Secondary 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. Day 1 and Week 12 No
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