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

Actegy Ltd.1 site in 1 country6 target enrollmentSeptember 2013

ConditionsCystic Fibrosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Actegy Ltd.
Enrollment: 6
Locations: 1
Primary Endpoint: Wet weight of sputum expectorated during treatment session
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

November 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Actegy Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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
•Current pulmonary embolism
•Oesophageal varices
•Recent thoracic upper gastro-intestinal tract or facial surgery

Outcomes

Primary Outcomes

Wet weight of sputum expectorated during treatment session

Time Frame: up to 30 minutes after treatment

Secondary Outcomes

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)