An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in participants with symptomatic moderate to severe chronic obstructive pulmonary disease (COPD).

Key facts

Study ID

NCT01867762

Run by

Janssen Research & Development, LLC

People needed

211

Starts

2013-09-09

Expected to finish

2014-09-01

Last updated by the study team

2019-08-21

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women of non-child-bearing potential, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2 or 3), forced expiratory volume in one second (FEV1) greater than or equal to 40 less than 80 percent predicted, FEV1/ forced vital capacity (FVC) ratio less than 0.7
• Clinical history of chronic bronchitis. Either two chronic obstructive pulmonary disease (COPD) exacerbations in past two years or ability to produce a spontaneous sputum sample, treated with long-acting beta-2 agonist (LABA)/ long-acting muscarinic antagonists (LAMA), with or without inhaled corticosteroids for at least 12 weeks prior to study entry
• Smoker or ex-smoker with at least a 10 pack-year history
• No COPD exacerbation that requires change in COPD maintenance medications during the screening period
• Not experienced a significant worsening of COPD based on clinical symptoms and by investigations during screening period

You may not qualify if…

• Has another pulmonary disease (eg, asthma) or an active infection (eg, tuberculosis)
• Has experienced life-threatening COPD (eg, requiring intensive care unit [ICU] admission, intubation, or long-term non-invasive ventilation). Short-term (less than five days), non-invasive ventilation during a hospitalization for an acute exacerbation of COPD is permitted, provided that non-invasive ventilation was not continued at home
• Has right heart failure or oxygen saturation less than 90 percent at rest on room air at screening or requires oxygen therapy on a daily basis for chronic hypoxemia (deficiency of oxygen in blood)
• History of significant disease or medical illness within 12 months prior to screening - Positive serology to human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B virus, or hepatitis C virus at screening

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — St Louis, Missouri, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Antwerp, Belgium
• Study site — Brussels, Belgium
• Study site — Genk, Belgium
• Study site — Kortrijk, Belgium
• Study site — Leuven, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Sainte-Foy, Quebec, Canada
• Study site — Sherbrooke, Quebec, Canada
• Study site — Prague, Czechia
• Study site — Berlin, Germany
• Study site — Frankfurt, Germany
• Study site — Großhansdorf, Germany
• Study site — Hamburg, Germany
• Study site — Lübeck, Germany

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.