Clinical trial NCT01867762: An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Inhaled JNJ 49095397 (RV568) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
JNJ 49095397
RV568
Forced expiratory volume in one second
FEV1
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 211
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 substance that is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, parallel-group (each group of participants will be treated at the same time) study. Approximately 200 participants will be randomly assigned to JNJ 49095397 or placebo in the ratio 1:1. The study consists of 3 phases: screening (3 weeks), double-blind treatment (12 weeks), and follow up (4 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests which will be monitored throughout the study. The total duration of the study for each participant will be approximately 19 weeks.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12
timeFrame: Baseline (Week 0) to Week 12
Secondary outcomes:
measure: Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12
timeFrame: Baseline (Week 0) to Week 12
measure: Number of participants with adverse events
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Saint Louis
country: United States
state: Missouri
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Spartanburg
country: United States
state: South Carolina
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Genk
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Prague 5
country: Czechia
city: Praha
country: Czechia
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Großhansdorf
country: Germany
city: Hamburg
country: Germany
city: Lübeck
country: Germany
city: Mainz
country: Germany
city: Budapest
country: Hungary
city: Farkasgyepü
country: Hungary
city: Mosonmagyaróvár
country: Hungary
city: Szikszó
country: Hungary
city: Eindhoven
country: Netherlands
city: Groningen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sittard / Geleen
country: Netherlands
city: Zwolle
country: Netherlands
city: Bialystok
country: Poland
city: Lodz
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Barnaul
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: Bristol
country: United Kingdom
city: Dundee
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: