GB43311
Aliento COPD Study
Study Title
A Phase IIB, randomised, double-blind, placebo-controlled, multi-centre study to evaluate the efficacy and safety of astegolimab in patients with chronic obstructive pulmonary disease.
Study duration
62 weeks – Main Study
Up to 4 years – Optional Extension Study
Number of CLINIC VISITS
29 visits – Main Study
Every 8-12 weeks until completion – Optional Extension Study
Main entry criteria
- 40 – 90 years of age
- Confirmed diagnosis of COPD
- Have had at least 2 COPD exacerbations requiring treatment with oral steroids or requiring hospitalisation over a continuous 12-month period within the past 24 months.
- Current or former cigarette smoker
- Taking medication(s) to treat your COPD
There are additional eligibility requirements to enrol in this study. Our Study Doctor will review the study requirements and discuss your eligibility with you either over the telephone or at your first clinic visit.
Assessments
- Breathing tests
- Blood pressure and pulse measurements
- Electronic Diary Questionnaires
- ECGs
- Blood tests
- Sputum sampling
You will receive all study-related procedures, medications, and laboratory services at no cost. In addition, you will be reimbursed $100 per visit for your time and travel.
D9180C00004
TITANIA COPD Study
Study Title
A Phase III, Multicentre, Randomised, Double-Blind, Chronic-dosing, Parallel-group, Placebo-controlled study to evaluate the efficacy and safety of two dose regimens of MEDI3506 in participants with symptomatic chronic obstructive pulmonary disease (COPD) with a history of COPD exacerbations (TITANIA)
Study duration
52 weeks – Main Study
60 weeks – Optional Extension study
Number of CLINIC VISITS
Up to 16 visits – Main Study
Up to 9 Visits and 5 Phone calls – Optional Extension study
Main entry criteria
- At least 40 years of age
- Confirmed diagnosis of COPD for at least 1 year
- Have had at least 2 COPD exacerbations requiring treatment with oral steroids or at least 1 COPD exacerbation requiring hospitalisation within the past 12 months.
- Current or former cigarette smoker
- Taking inhaled medication(s) (puffers) to treat your COPD
There are additional eligibility requirements to enrol in this study. Our Study Doctor will review the study requirements and discuss your eligibility with you either over the telephone or at your first clinic visit.
Assessments
- Breathing tests
- Blood pressure and pulse measurements
- Electronic Diary Questionnaires
- ECGs
- Blood and urine tests
You will receive all study-related procedures, medications, and laboratory services at no cost. In addition, you will be reimbursed $70 per visit for your time and travel.
D3251C00014
RESOLUTE COPD Study
Study Title
A Multi-centre, Randomized, Double-Blind, Chronic-Dosing, Parallel-Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 g in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE).
Study duration
Up to 3 years
Number of CLINIC VISITS
Up to 23 clinic visits
Number of phone calls
Up to 19 phone calls
Main entry criteria
- 40-85 years of age
- Confirmed diagnosis of COPD
- Current or former cigarette smoker
- Have had at least 2 COPD exacerbations requiring treatment with oral steroids or requiring hospitalisation in the past 12 months
- Taking inhaled medication to treat your COPD
There are additional eligibility requirements to enrol in this study. Our Study Doctor will review the study requirements and discuss your eligibility with you either over the telephone or at your first clinic visit.
Assessments
- Breathing tests
- Blood pressure and pulse
- Questionnaires
- ECGs
- Blood tests
You will receive all study-related procedures, medications, and laboratory services at no cost. In addition, you will be reimbursed $50 per visit for your time and travel.