An Efficacy And Safety of CNTO 6785 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease; MedDRA version: 16.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003607-36-CZ
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-15
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Be male or female and =40 years and =75 years of age.
• Have moderate to severe chronic obstructive pulmonary disease (COPD, Grade II or Grade III according to the GOLD Guidelines
• Have persistent COPD symptoms that required repeated (>1) ‘as needed’ use of a short-acting rescue medication within 4 weeks prior to Study Visit 1.
• Have a diagnosis of chronic bronchitis (defined as sputum production on most days for at least 12 weeks per year for at least 2 successive years) reported by the subject at Study Visit 1.
• Be able to meet at least 1 of the following 2 criteria: have had at least 2 COPD exacerbations requiring antibiotics and/or systemic corticosteroids in the past 2 years; or be able to spontaneously produce an adequate sputum sample at Study Visit 1 or Study Visit 2.
• Be a current or ex-smoker who has a smoking history of at least 10 pack years (10 pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) at Study Visit 1.
• Have been treated with stable dose of LABA and/or long-acting anticholinergic bronchodilators alone or in combination with ICS for at least 4 weeks prior to Study Visit 1.
• Have a percent-predicted post-BD FEV1 =40% and <80%, and a post BD FEV1/FVC <0.70 at Visit 1.
• Have a post-BD FEV1 >500 mL at Study Visit 1. Participants in the bronchoscopy substudy must have a post-BD FEV1 >800 mL at Study Visit 1 and Study Visit 2
• No active, old, or latent tuberculosis (TB), and no close contact with active TB patients within 3 months prior to Study visit 1.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 68

Exclusion Criteria

• Has a body mass index (BMI) >32.0 kg/m2.
• Has another pulmonary disease, eg, asthma, clinically significant bronchiectasis, cystic fibrosis, sarcoidosis, interstitial lung disorder, moderate or severe sleep apnea, or pulmonary hypertension at Study Visit 1.
• Has a history of granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to Study Visit 1.
• Has ever experienced life-threatening COPD (eg, intensive care unit [ICU] admission, intubation, non-invasive ventilation).
• Has had a lung lobectomy, lung cancer surgery, lung volume reduction, or a lung transplant.
• Has had any of the following respiratory tract conditions within the specified time intervals: pneumonia (as confirmed by chest x-ray findings and treated with antibiotics) within 1 year prior to Study Visit 1; COPD exacerbation that required systemic steroids and/or antibiotics or required hospitalization and was not associated with pneumonia within 6 weeks prior to Study Visit 1; upper or lower respiratory tract infection (including common cold or sinusitis) that was not associated with either pneumonia or COPD exacerbation within 4 weeks prior to Study Visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified