Pilaster - New add on therapy to help treat chronic obstructive pulmonary disease with chronic bronc

Pilaster - New add on therapy to help treat chronic obstructive pulmonary disease with chronic bronchitis

Chronic obstructive pulmonary disease (COPD) with Chronic Bronchitis

The purpose of the PILASTER Study is to see how safe and effective a new investigational medication is for treating COPD. The new investigational medication is referred to as CHF6001 (called the “Study Drug” in this brochure). The Study Drug is to be inhaled and will be added on to the current maintenance triple therapy taken by study participants.

For some people with COPD and chronic bronchitis, maintenance triple therapy does not adequately relieve their symptoms, which can lead to serious exacerbations. For people who still have COPD symptoms, such as the participants in the PILASTER Study, additional treatments are needed to add on to existing maintenance triple therapies.

Category
Respiratory, Infectious Disease and Oncology
Trial status
Recruiting
Trial phase
Phase 3 Drug Trial
Late stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
Registry listing
ClinicalTrials.gov: NCT04636801
ERM Project ID
92094

Trial contact details

Contact person
RIO Clinical Trials Unit
Email
RIOClinicalTrials@mater.org.au
Phone
07 3163 1369

What you need to know

Who can take part?

Adults aged ≥ 40 years with COPD and chronic bronchitis
Current or ex-smokers (history ≥ 10 pack years).
Post-bronchodilator FEV1 < 0.7.
At least, one moderate or severe COPD exacerbation in previous year.
CAT score ≥ 10
Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit.