NCT01923753

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

August 13, 2013

Last Update Submit

June 2, 2016

Conditions

Cystic Fibrosis

Keywords

Cystic FibrosisNeural respiratory driveAirway clearance techniqueExpectorationPositive expiratory pressure device

Outcome Measures

Primary Outcomes (1)

  • Wet weight of sputum expectorated during treatment session

    up to 30 minutes after treatment

Secondary Outcomes (5)

  • 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 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

Study Arms (3)

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.

Device: Aerosure at 15 Hz

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.

Device: Aerosure at 25 Hz

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.

Device: Sham Aerosure

Interventions

Aerosure at 15 HzDEVICE

Active Aerosure HFAO device operating at lower frequency

Aerosure 15 Hz
Aerosure at 25 HzDEVICE

Active Aerosure HFAO device operating at higher frequency

Aerosure 25 Hz
Sham AerosureDEVICE

Deactivated but identical Aerosure HFAO device

Aerosure sham

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital, Bessemer Road, Denmark Hill

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • John Moxham, MD

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 16, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

GB(1)