A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01923753
• Other study ID #: ACACIA-01
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2013
• Last updated: June 2, 2016
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: Actegy Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Aerosure at 15 Hz
Active Aerosure HFAO device operating at lower frequency
• Aerosure at 25 Hz
Active Aerosure HFAO device operating at higher frequency
• Sham Aerosure
Deactivated but identical Aerosure HFAO device

Locations

Country	Name	City	State
United Kingdom	King's College Hospital, Bessemer Road, Denmark Hill	London

Sponsors (1)

Lead Sponsor	Collaborator
Actegy Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wet weight of sputum expectorated during treatment session		up to 30 minutes after treatment	No
Secondary	Change in FEV1		immediately before and up to 30 minutes after treatment	No
Secondary	Change in VC		immediately before and up to 30 minutes after treatment	No
Secondary	Change in oxygen saturation		continuously from 3 minutes prior to treatment and until 3 minutes after treatment	No
Secondary	Change in ventilation		5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment	No
Secondary	Change in neural respiratory drive		5 minutes prior to treatment and 30 minutes after treatment	No