SPRAY-CB Pivotal Study
Research type
Research Study
Full title
A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)
IRAS ID
304514
Contact name
Heather Nigro
Contact email
Sponsor organisation
CSA Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 16 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. The primary objective of this trial is to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adult subjects with a diagnosis of CB defined as COPD with classic 3 months of cough and sputum production for a minimum of 2 years who demonstrate ongoing symptoms of cough and significant mucus production. The study will enroll approximately 210 subjects who will be treated by an interventional pulmonologist. Eligible subjects will be randomized 2:1 to Treatment Arm vs. Sham Control Arm. Those randomized to the Sham Control Arm will have the option to cross over to the treatment arm after the 12 month follow up visit. Patients in this study will be followed for 24 months.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
22/NW/0279
Date of REC Opinion
12 Dec 2022
REC opinion
Further Information Favourable Opinion