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

NCT01834885 | Withdrawn Phase 3

• 1 other identifier: CQVA149A2327
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 29

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

• Transition Dyspnea Index (TDI) Focal Score

  Week 12

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

  Week 12

• Change from baseline in daily number of puffs of rescue medication

  Week 12

• Daily symptoms reported by patient

  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/slameterol 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+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (29)

Novartis Investigative Site

Feldkirch, Austria, 6800, Austria

Location

Novartis Investigative Site

Grieskirchen, Austria, 4710, Austria

Location

Novartis Investigative Site

Hallein, Austria, 5400, Austria

Location

Novartis Investigative Site

Linz, Austria, 4020, Austria

Location

Novartis Investigative Site

Thalheim bei Wels, Austria, 4600, Austria

Location

Novartis Investigative Site

Wels, Austria, 4600, Austria

Location

Novartis Investigative Site

Berlin, Germany, 10117, Germany

Location

Novartis Investigative Site

Dresden, Germany, 01307, Germany

Location

Novartis Investigative Site

Leipzig, Germany, 04207, Germany

Location

Novartis Investigative Site

Potsdam, Germany, 14467, Germany

Location

Novartis Investigative Site

Aschaffenburg, 63739, Germany

Location

Novartis Investigative Site

Bad Wörishofen, 86825, Germany

Location

Novartis Investigative Site

Berlin, 10119, Germany

Location

Novartis Investigative Site

Berlin, 10717, Germany

Location

Novartis Investigative Site

Berlin, 10789, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Berlin, 12687, Germany

Location

Novartis Investigative Site

Berlin, 13156, Germany

Location

Novartis Investigative Site

Frankfurt, 60389, Germany

Location

Novartis Investigative Site

Frankfurt, 60596, Germany

Location

Novartis Investigative Site

Großhansdorf, 22947, Germany

Location

Novartis Investigative Site

Hamburg, 20253, Germany

Location

Novartis Investigative Site

Hamburg, 20354, Germany

Location

Novartis Investigative Site

Hamburg, 22335, Germany

Location

Novartis Investigative Site

Hanover, 30317, Germany

Location

Novartis Investigative Site

Leipzig, 04357, Germany

Location

Novartis Investigative Site

Lübeck, 23552, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Rheine, 48431, Germany

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: April 18, 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

DE (23); AU (6)