Evaluation of the Effectiveness of The Volara System Determined by Sputum Movement and Production
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorBaxter Healthcare Corporation
About this trial
The aim of this study is to evaluate the therapeutic effect of therapy with The Volara System on mucus clearance.
Eligibility criteria
Qualifiers
Documented diagnosis of COPD with or without bronchiectasis.
Age ≥ 21 years.
Naive to Volara therapy.
FEV1 < 80% predicted (based on pulmonary function tests within the past 12 months).
Disqualifiers
Anticipated requirement for hospitalisation within the next 35 days (± 1 day).
History of pneumothorax within the past 6 months prior to visit 1.
History of haemoptysis requiring embolization within the past 12 months prior to visit 1.
Inability or unwillingness to perform Volara System therapy as directed, without healthcare provider support.
Trial design
Treatments tested in this trial
- Volara therapy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov