Status:
COMPLETED
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01867762
Start Date
September 9 2013
End Date
September 1 2014
Last Update
August 21 2019
Active Locations (47)
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1
Phoenix, Arizona, United States
2
St Louis, Missouri, United States
3
Chapel Hill, North Carolina, United States
4
Charlotte, North Carolina, United States