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Should Any One Airway Clearance Technique be Recommended for People With Cystic Fibrosis?

NCT ID: NCT00890370

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2003-09-30

Brief Summary

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The study was to evaluate the long term effects, over one year, of five airway clearance techniques used by people with cystic fibrosis (active cycle of breathing techniques, autogenic drainage, positive expiratory pressure and oscillating positive expiratory pressure (R-C Cornet and Flutter)). The primary outcome measure was forced expiratory volume in one second (FEV1)and the null hypothesis was that there are no differences among the regimens.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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Cystic fibrosis Airway clearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Active cycle of breathing techniques

Group Type OTHER

Airway clearance technique

Intervention Type PROCEDURE

2

Autogenic drainage

Group Type OTHER

Airway clearance technique

Intervention Type PROCEDURE

3

R-C Cornet

Group Type OTHER

Airway clearance technique

Intervention Type PROCEDURE

4

Flutter

Group Type OTHER

Airway clearance technique

Intervention Type PROCEDURE

5

PEP

Group Type OTHER

Airway clearance technique

Intervention Type PROCEDURE

Interventions

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Airway clearance technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cystic fibrosis (genotype or sweat sodium concentration greater than 70 mmol/litre)
* Forced expiratory volume in one second greater than or equal to 25% predicted, on assessment for entry to the study.

Exclusion Criteria

* Evidence of a current respiratory exacerbation (Thornton et al 2004)
* Current severe haemoptysis
* Past history of pneumothorax
* Awaiting lung / heart-lung transplantation
* Pregnancy
* Recent (within 3 months) acquisition of Burkholderia cepacia
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brompton & Harefield NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Brompton & Harefield NHS Trust

Principal Investigators

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Jennifer A Pryor, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Brompton & Harefield NHS Foundation Trust

Other Identifiers

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1998CF004B

Identifier Type: -

Identifier Source: org_study_id