A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Phase 2
Terminated
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT01923753
- Lead Sponsor
- Actegy Ltd.
- Brief Summary
This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- A diagnosis of CF (established by genotype or sweat sodium >70mmol/l or sweat chloride of >60 mmol/l
- Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics
Exclusion Criteria
- Acute respiratory failure
- Haemodynamic instability (including severe right heart failure with hypotension)
- Current severe haemoptysis
- Ineffective cough
- Rib fractures
- Pregnancy
- Current or recent pneumothorax
- Epilepsy
- Current pulmonary embolism
- Oesophageal varices
- Recent thoracic upper gastro-intestinal tract or facial surgery
- Active tuberculosis
- Recent brain, eye, ear, ENT surgery
- Myocardial infarction
- Ascending aortic aneurysm
- Acute diarrhoea
- Pulmonary embolism
- Angina
- Severe hypertension (systolic >200 mm Hg, diastolic >120 mm Hg)
- Confusion/dementia
- Inability to give consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Wet weight of sputum expectorated during treatment session up to 30 minutes after treatment
- Secondary Outcome Measures
Name Time Method Change in ventilation 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment Change in FEV1 immediately before and up to 30 minutes after treatment Change in VC immediately before and up to 30 minutes after treatment Change in oxygen saturation continuously from 3 minutes prior to treatment and until 3 minutes after treatment Change in neural respiratory drive 5 minutes prior to treatment and 30 minutes after treatment
Trial Locations
- Locations (1)
King's College Hospital, Bessemer Road, Denmark Hill
🇬🇧London, United Kingdom
King's College Hospital, Bessemer Road, Denmark Hill🇬🇧London, United Kingdom