Long Term Safety Study of NVA237 vs QAB149 in COPD Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.

Key facts

Study ID

NCT01697696

Run by

Novartis Pharmaceuticals

People needed

511

Starts

2012-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-03-16

Who can join

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

You may qualify if…

• Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
• Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
• Current or ex-smokers with a smoking history of at least 10 pack years
• Patients with a mMRC score of at least 2 at run-in.

You may not qualify if…

• Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
• Patients with a history of malignancy of any organ system, treated or untreated, within the last five years
• Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention
• Patients who had a COPD exacerbation within 6 weeks prior to screening.
• Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
• Patients with a history of asthma.
• Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
• Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
• Patients with concomitant pulmonary disease
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a diagnosis of alpha-1 anti-trypsin deficiency
• Patients with active pulmonary tuberculosis
• Patients in the active phase of a pulmonary rehabilitation programme
• Other protocol-defined inclusion / exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Riverside, California, United States
• Novartis Investigative Site — Fort Collins, Colorado, United States
• Novartis Investigative Site — Wheat Ridge, Colorado, United States
• Novartis Investigative Site — Glastonbury, Connecticut, United States
• Novartis Investigative Site — Stamford, Connecticut, United States
• Novartis Investigative Site — Waterbury, Connecticut, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Hialeah, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Oakland Park, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Couer D'Alene, Idaho, United States
• Novartis Investigative Site — Newburgh, Indiana, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Florence, Kentucky, United States
• Novartis Investigative Site — Madisonville, Kentucky, United States
• Novartis Investigative Site — New Orleans, Louisiana, United States
• Novartis Investigative Site — Opelousas, Louisiana, United States
• Novartis Investigative Site — Biddeford, Maine, United States
• Novartis Investigative Site — Worchester, Massachusetts, United States
• Novartis Investigative Site — Gulf Shores, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.