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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01860066
• Other study ID #: CQVA149A2328
• Status: Withdrawn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• Status: Withdrawn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

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	Mendoza
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Gilly
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Jambes
Colombia	Novartis Investigative Site	Barranquilla
Colombia	Novartis Investigative Site	Florida Blanca
Colombia	Novartis Investigative Site	Medellín
Czech Republic	Novartis Investigative Site	Cvikov
Czech Republic	Novartis Investigative Site	Jindrichuv Hradec
Czech Republic	Novartis Investigative Site	Karlovy Vary
Czech Republic	Novartis Investigative Site	Kurim
Czech Republic	Novartis Investigative Site	Kyjov	CZE
Czech Republic	Novartis Investigative Site	Pardubice
Czech Republic	Novartis Investigative Site	Teplice
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Faridabad	Haryana
India	Novartis Investigative Site	Guntur	Andhra Pradesh
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Karamsad
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Belgium,  Colombia,  Czech Republic,  India, 

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	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
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