BridgeMD
A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease (COPD)
EU CTIS ID: 2023-507093-40-00
What this study is testing
To evaluate the effect of astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 40-90 years
- Documented physician diagnosis of COPD for at least 12 months
- History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
- Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
- Current or former smoker with a minimum of 10 pack-year history
- History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA) Long-acting muscarinic antagonist (LAMA) plus LABA ICS plus LAMA plus LABA
You likely can't join if
- Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
- History of clinically significant pulmonary disease other than COPD (e.g. pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency)
- Lung volume reduction surgery or procedure within 12 months prior to screening
- History of lung transplant
- Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of >= 24 hours duration within 4 weeks prior to initiation of study drug
- History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of >= 89%
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Canada
- Peru
- Hong Kong
- Korea, Republic of
- Mexico
- South Africa
- United Kingdom
- New Zealand
- Argentina
- Israel
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Canada; Peru; Hong Kong; Korea, Republic of; Mexico and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.