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Unable to recruit sufficient patients within reasonable timeframe
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerosure 15 Hz | Experimental | All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure. Order of presentation is randomised. |
|
| Aerosure 25 Hz | Active Comparator | All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure. |
|
| Aerosure sham | Sham Comparator | All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosure at 15 Hz | Device | Active Aerosure HFAO device operating at lower frequency |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wet weight of sputum expectorated during treatment session | up to 30 minutes after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Moxham, MD | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital, Bessemer Road, Denmark Hill | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Aerosure at 25 Hz |
| Device |
Active Aerosure HFAO device operating at higher frequency |
|
| Sham Aerosure | Device | Deactivated but identical Aerosure HFAO device |
|
| continuously from 3 minutes prior to treatment and until 3 minutes after treatment |
| Change in ventilation | 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment |
| Change in neural respiratory drive | 5 minutes prior to treatment and 30 minutes after treatment |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |