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)



  • 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


  • Date of REC Opinion

    12 Dec 2022

  • REC opinion

    Further Information Favourable Opinion