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

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Primary Purpose

Status

Withdrawn

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

QVA149

fluticasone/salmeterol

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QVA149

fluticasone/salmeterol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

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.

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.

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.

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.

Safety and tolerability

All adverse events and serious adverse events (SAEs) will be reported.

Full Information

NCT ID

NCT01860066

First Posted

April 15, 2013

Last Updated

November 8, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01860066

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Withdrawn

Study Start Date

December 2013 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QVA149

Arm Type

Experimental

Arm Description

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.

Arm Title

fluticasone/salmeterol

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

QVA149

Intervention Description

QVA149 via inhaler twice a day

Intervention Type

Drug

Intervention Name(s)

fluticasone/salmeterol

Intervention Description

fluticasone/salmeterol via inhaler twice a day

Primary Outcome Measure Information:

Title

Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment

Description

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

Secondary Outcome Measure Information:

Title

Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatment

Description

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

Title

Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose

Description

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

Title

Area under the curve (AUC) 0-4 hours for FEV1

Description

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

Title

Transition Dyspnea Index (TDI) Focal Score

Description

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

Title

Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ)

Description

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

Title

Change from baseline in daily number of puffs of rescue medication

Description

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

Title

Daily symptoms reported by patient

Description

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

Title

COPD assessment (CAT) test

Description

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

Title

Safety and tolerability

Description

All adverse events and serious adverse events (SAEs) will be reported.

Time Frame

Over 12 weeks

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1115AAB

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

M5500CBA

Country

Argentina

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Jambes

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Florida Blanca

Country

Colombia

Facility Name

Novartis Investigative Site

City

Medellín

Country

Colombia

Facility Name

Novartis Investigative Site

City

Kyjov

State/Province

CZE

ZIP/Postal Code

697 70

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Cvikov

ZIP/Postal Code

471 54

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Karlovy Vary

ZIP/Postal Code

360 66

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Kurim

ZIP/Postal Code

664 34

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Pardubice

ZIP/Postal Code

530 09

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Teplice

ZIP/Postal Code

415 01

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Guntur

State/Province

Andhra Pradesh

ZIP/Postal Code

522 001

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380 008

Country

India

Facility Name

Novartis Investigative Site

City

Faridabad

State/Province

Haryana

ZIP/Postal Code

121 001

Country

India

Facility Name

Novartis Investigative Site

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560 002

Country

India

Facility Name

Novartis Investigative Site

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

400 012

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411004

Country

India

Facility Name

Novartis Investigative Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302004

Country

India

Facility Name

Novartis Investigative Site

City

Karamsad

ZIP/Postal Code

388225

Country

India

Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial