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

NCT01867762 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: CR10180749095397OPD20012012-005184-27
• Study Type: interventional
• Target: 211
• Locations: 11 countries
• Sites: 47

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; JNJ 49095397; RV568; Forced expiratory volume in one second; FEV1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12

  FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

  Baseline (Week 0) to Week 12

Secondary Outcomes (5)

• Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12

  Baseline (Week 0) to Week 12

• Change From Baseline in Weekly Average Number of Occasions in a day that Rescue Medication is Used at Week 12

  Baseline (Week 0) to Week 12

• Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12

  Baseline (Week 0) to Week 12

• Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) at Week 12

  Baseline (Week 0) to Week 12

• Number of participants with adverse events

  Up to 16 weeks

Study Arms (2)

JNJ 49095397

EXPERIMENTAL

Drug: JNJ 49095397

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ 49095397 DRUG

JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

JNJ 49095397

Placebo DRUG

Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (47)

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Phoenix, Arizona, United States

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St Louis, Missouri, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Spartanburg, South Carolina, United States

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Antwerp, Belgium

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Brussels, Belgium

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Genk, Belgium

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Kortrijk, Belgium

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Leuven, Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Prague, Czechia

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Berlin, Germany

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Frankfurt, Germany

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Großhansdorf, Germany

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Hamburg, Germany

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Lübeck, Germany

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Mainz, Germany

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Budapest, Hungary

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Farkasgyepü, Hungary

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Mosonmagyaróvár, Hungary

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Szikszó, Hungary

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Eindhoven, Netherlands

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Groningen, Netherlands

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Rotterdam, Netherlands

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Sittard / Geleen, Netherlands

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Zwolle, Netherlands

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Bialystok, Poland

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Lodz, Poland

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Wroclaw, Poland

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Bucharest, Romania

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Barnaul, Russia

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Moscow, Russia

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Saint Petersburg, Russia

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Bristol, United Kingdom

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Dundee, United Kingdom

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Edinburgh, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: September 9, 2013
• Primary Completion: August 6, 2014
• Study Completion: September 1, 2014
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

RO (1); DE (6); GB (5); CA (8); CZ (1); NL (5); HU (4); BE (5); PL (3); RU (3); US (6)