Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

This study was designed to investigate the efficacy and safety of NVA237, a long-acting muscarinic antagonist, in patients with moderate to severe COPD.

Key facts

Study ID

NCT01119950

Run by

Novartis Pharmaceuticals

People needed

388

Starts

2010-04-01

Expected to finish

2010-12-01

Last updated by the study team

2015-03-23

Who can join

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

You may qualify if…

• Male and female patients age 40 years or more
• Diagnosis of Chronic Obstructive Lung Disease (COPD) (moderate to severe as classified by the Global Initiative for COPD (GOLD) Guidelines, 2008
• Smoking history of at least 10 pack-years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.7
• Symptomatic patients, according to daily electronic diary data between visit 2 (Day -8) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to visit 3

You may not qualify if…

• Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to the first visit
• Patients who have had a respiratory tract infection within 4 weeks prior to the first visit
• Patients with concomitant pulmonary disease
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a history of asthma or a blood eosinophil count >600/mm3 or onset of symptoms prior to 40 years
• Patients with eczema, known high IgE levels or a known positive skin prick test
• Patients participating in the active phase of a pulmonary rehabilitation programme
• Patients contraindicated for the treatment with anticholinergics, long and short-acting beta-2 agonists or sympathomimetic amines
• Patients with a history of alpha-1 anti-trypsin deficiency
• Patients on long term oxygen therapy (>15hr per day)
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Anniston, Alabama, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Torrance, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Antwerp, Belgium
• Novartis Investigative Site — Genk, Belgium
• Novartis Investigative site — Jambes, Belgium
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Balassagyarmat, Hungary
• Novartis Investigative Site — Balatonfüred, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Szolnok, Hungary
• Novartis Investigative Site — Törökbálint, Hungary
• Novartis Investigative Site — Almelo, Netherlands
• Novartis Investigative Site — Eindhoven, Netherlands
• Novartis Investigative Site — Harderwijk, Netherlands
• Novartis Investigative Site — Heerlen, Netherlands
• Novartis Investigative Site — Helmond, Netherlands
• Novartis Investigative Site — Veldhoven, Netherlands
• Novartis Investigative Site — Zutphen, Netherlands
• Novartis Investigative Site — Izabelin, Poland
• Novartis Investigative Site — Lodz, Poland

Full record on ClinicalTrials.gov

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