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

NCT01860066 | Withdrawn Phase 3

• 1 other identifier: CQVA149A2328
• Study Type: interventional
• Target: N/A
• Locations: 5 countries
• Sites: 31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

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

  Day 1 and Week 12

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

  Day 1 and Week 12

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

  Day 1 and Week 12

• Transition Dyspnea Index (TDI) Focal Score

  Week 12

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

  Week 12

Study Arms (2)

QVA149

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Interventions

QVA149 DRUG

QVA149 via inhaler twice a day

QVA149

fluticasone/salmeterol DRUG

fluticasone/salmeterol via inhaler twice a day

fluticasone/salmeterol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (31)

Novartis Investigative Site

Buenos Aires, Buenos Aires, 1425, Argentina

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1115AAB, Argentina

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1122AAK, Argentina

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, Argentina

Location

Novartis Investigative Site

Mendoza, Mendoza Province, 5500, Argentina

Location

Novartis Investigative Site

Mendoza, Mendoza Province, M5500CBA, Argentina

Location

Novartis Investigative Site

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Novartis Investigative Site

Antwerp, 2060, Belgium

Location

Novartis Investigative Site

Brussels, 1000, Belgium

Location

Novartis Investigative Site

Genk, 3600, Belgium

Location

Novartis Investigative Site

Gilly, 6060, Belgium

Location

Novartis Investigative Site

Hasselt, 3500, Belgium

Location

Novartis Investigative Site

Jambes, 5100, Belgium

Location

Novartis Investigative Site

Barranquilla, Colombia

Location

Novartis Investigative Site

Florida Blanca, Colombia

Location

Novartis Investigative Site

Medellín, Colombia

Location

Novartis Investigative Site

Cvikov, Czech Republic, 471 54, Czechia

Location

Novartis Investigative Site

Jindřichův Hradec, Czech Republic, 377 01, Czechia

Location

Novartis Investigative Site

Karlovy Vary, Czech Republic, 360 66, Czechia

Location

Novartis Investigative Site

Kuřim, Czech Republic, 664 34, Czechia

Location

Novartis Investigative Site

Pardubice, Czech Republic, 530 09, Czechia

Location

Novartis Investigative Site

Teplice, Czech Republic, 415 01, Czechia

Location

Novartis Investigative Site

Kyjov, CZE, 697 70, Czechia

Location

Novartis Investigative Site

Guntur, Andhra Pradesh, 522 001, India

Location

Novartis Investigative Site

Ahmedabad, Gujarat, 380 008, India

Location

Novartis Investigative Site

Faridabad, Haryana, 121 001, India

Location

Novartis Investigative Site

Karamsad, India, 388225, India

Location

Novartis Investigative Site

Bangalore, Karnataka, 560 002, India

Location

Novartis Investigative Site

Nagpur, Maharashtra, 400 012, India

Location

Novartis Investigative Site

Pune, Maharashtra, 411004, India

Location

Novartis Investigative Site

Jaipur, Rajasthan, 302004, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol-glycopyrronium combination; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: May 22, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 11, 2013

Record last verified: 2013-11

Locations

BE (6); IN (8); AR (7); CO (3); CZ (7)