Chronic Obstructive Pulmonary DiseasePhase 2NCT01867762
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing JNJ 49095397 in people with Chronic Obstructive Pulmonary Disease, run by Janssen Research & Development, LLC at 47 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- JNJ 49095397
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 47 sitesin 11 countries
- Study dates
- 9 Sep 2013to 1 Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
47 sites in 11 countries.
47 sites in 11 countries
Canada8 sites
Study site
Calgary, Alberta
Study site
Edmonton, Alberta
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Sainte-Foy, Quebec
Study site
Sherbrooke, Quebec
Study site
Toronto, Ontario
United States6 sites
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Phoenix, Arizona
Study site
Spartanburg, South Carolina
Study site
St Louis, Missouri
Germany6 sites
Study site
Berlin
Study site
Frankfurt
Study site
Großhansdorf
Study site
Hamburg
Study site
Lübeck
Study site
Mainz
Belgium5 sites
Study site
Antwerp
Study site
Brussels
Study site
Genk
Study site
Kortrijk
Study site
Leuven
Netherlands5 sites
Study site
Eindhoven
Study site
Groningen
Study site
Rotterdam
Study site
Sittard / Geleen
Study site
Zwolle
United Kingdom5 sites
Study site
Bristol
Study site
Dundee
Study site
Edinburgh
Study site
Glasgow
Study site
London
Hungary4 sites
Study site
Budapest
Study site
Farkasgyepü
Study site
Mosonmagyaróvár
Study site
Szikszó
About this study
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
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).
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- JNJ 49095397, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, JNJ 49095397, RV568, Forced expiratory volume in one second, FEV1
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ 49095397Drug
JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
PlaceboDrug
Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JNJ 49095397 | Experimental | Not described Receives: Drug: JNJ 49095397 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) to Week 12
Secondary outcomes (5)
Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) 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.
Measured: 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
Use of inhaled rescue medication (expressed as the number of occasions) taken on a schedule and/or for control of symptoms will be recorded twice daily.
Measured: Baseline (Week 0) to Week 12
Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12
E-RS is an 11-items respiratory system scoring algorithm to assess the severity of respiratory symptoms in participants with chronic obstructive pulmonary disease (COPD). Each item has either 5 or 6 response options. Higher score indicates more severe COPD.
Measured: 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
SGRQ-C is a 40-item questionnaire designed to measure health impairment in participants with COPD. SGRQ-C is divided into two components: 1) symptoms, 2) activity\& impacts. Total SGRQ-C score ranges from 0 (best) and 100 (worst). Higher scores indicate greater health impairment.
Measured: Baseline (Week 0) to Week 12
Number of participants with adverse events
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start9 Sep 2013
- Primary completion6 Aug 2014
- Study completion1 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867762
- Sponsor's protocol ID
- CR101807
- Other IDs
- 49095397OPD2001, 2012-005184-27
- Status last verified
- Aug 2019
- First submitted
- 30 May 2013
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01867762
- Acronym / sponsor ID
- CR101807
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, JNJ 49095397, RV568, Forced expiratory volume in one second, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 6 Aug 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ 49095397 | Experimental | Drug: JNJ 49095397 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ 49095397JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks. | Drug | JNJ 49095397 |
| PlaceboPlacebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12
Time frame: Baseline (Week 0) to 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.
5 secondary outcomes
Change From Baseline in Postbronchodilator (postBD, after taking an inhaled bronchodilator) FEV1 at Week 12
Time frame: 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
Time frame: Baseline (Week 0) to Week 12
Change From Baseline in EXAcerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) at Week 12
Time frame: 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
Time frame: Baseline (Week 0) to Week 12
Number of participants with adverse events
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
47 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ 49095397 in people with Chronic Obstructive Pulmonary Disease, run by Janssen Research & Development, LLC at 47 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Canada, United States, Germany, Belgium, Netherlands and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Prebronchodilator (preBD, before taking an inhaled bronchodilator) Percent-predicted Forced Expiratory Volume in one Second (FEV1) at Week 12 (time frame: Baseline (Week 0) to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.