A Multi-centre Randomized Double Blind 52-week Study to Assess the Safety of QVA149 Compared to QAB149 in Patients With COPD Who Have Moderate to Severe Airflow Limitation

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

This study is to assess the safety and tolerability of two different doses of QVA149 and QAB149 in patients with moderate to severe airflow limitation.

Key facts

Study ID

NCT01682863

Run by

Novartis Pharmaceuticals

People needed

614

Starts

2012-10-01

Expected to finish

2014-06-01

Last updated by the study team

2016-03-30

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults aged ≥40 years
• Patients with stable COPD according to GOLD strategy (GOLD 2011).
• Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥ 30% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70.
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• Patients with an mMRC ≥ grade 2

You may not qualify if…

• History of long QT syndrome or prolonged QTc
• Patients who have had a COPD exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.
• Patients with Type I or uncontrolled Type II diabetes
• Patients with a history of asthma or have concomitant pulmonary disease
• Patients with paroxysmal (e.g. intermittent) atrial fibrillation. Only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible
• Patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety
• Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Lakewood, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Stockton, California, United States
• Novartis Investigative Site — Walnut Creek, California, United States
• Novartis Investigative Site — Boulder, Colorado, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Lombard, Illinois, United States
• Novartis Investigative Site — O'Fallon, Illinois, United States
• Novartis Investigative Site — Peoria, Illinois, United States
• Novartis Investigative Site — Evansville, Indiana, United States
• Novartis Investigative Site — Ames, Iowa, United States
• Novartis Investigative Site — Iowa City, Iowa, United States
• Novartis Investigative Site — Waterloo, Iowa, United States
• Novartis Investigative Site — Bowling Green, Kentucky, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Slidell, Louisiana, United States
• Novartis Investigative Site — Bangor, Maine, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Livonia, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Picayune, Mississippi, United States
• Novartis Investigative Site — Vestavia Hills, Alabama, United States

Full record on ClinicalTrials.gov

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