Safety and Efficacy of Multiple Doses of QAX028 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.

Key facts

Study ID

NCT01068613

Run by

Novartis Pharmaceuticals

People needed

62

Starts

2010-01-01

Expected to finish

2010-08-01

Last updated by the study team

2020-12-19

Who can join

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

You may qualify if…

• Diagnosis of COPD according to GOLD guidelines
• Post-bronchodilator 30%≤FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7
• Smoking history of at least 10 pack years

You may not qualify if…

• Requiring oxygen therapy on a daily basis
• Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing
• Lung reduction surgery
• Respiratory tract infection in the 6 weeks prior to screening
• Significant cardiac history
• History of asthma with onset of symptoms prior to age 40 years
• Active use of certain COPD medications, beta blockers
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Advanced Clinical Research Institute, 1211 W. La Palma Ave — Anaheim, California, United States
• Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive — Normal, Illinois, United States
• Spartanburg Medical Research, 485 Simuel Road — Spartanburg, South Carolina, United States
• New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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