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| ID | Type | Description | Link |
|---|---|---|---|
| 49095397OPD2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2012-005184-27 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ 49095397 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ 49095397 | Drug | JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Week 0) to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Placebo | Drug | Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks. |
|
| 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. |
| 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. | 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. | Baseline (Week 0) to Week 12 |
| Number of participants with adverse events | Up to 16 weeks |
| St Louis |
| Missouri |
| United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Spartanburg | South Carolina | United States |
| Antwerp | Belgium |
| Brussels | Belgium |
| Genk | Belgium |
| Kortrijk | Belgium |
| Leuven | Belgium |
| Calgary | Alberta | Canada |
| Edmonton | Alberta | Canada |
| Hamilton | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sainte-Foy | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| Prague | Czechia |
| Berlin | Germany |
| Frankfurt | Germany |
| Großhansdorf | Germany |
| Hamburg | Germany |
| Lübeck | Germany |
| Mainz | Germany |
| Budapest | Hungary |
| Farkasgyepü | Hungary |
| Mosonmagyaróvár | Hungary |
| Szikszó | Hungary |
| Eindhoven | Netherlands |
| Groningen | Netherlands |
| Rotterdam | Netherlands |
| Sittard / Geleen | Netherlands |
| Zwolle | Netherlands |
| Bialystok | Poland |
| Lodz | Poland |
| Wroclaw | Poland |
| Bucharest | Romania |
| Barnaul | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Bristol | United Kingdom |
| Dundee | United Kingdom |
| Edinburgh | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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