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

Royal Brompton & Harefield NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Procedure: Airway clearance technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00890370

1998CF004B

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 5 patient groups

1

Other group

Description:

Active cycle of breathing techniques

Treatment:

Procedure: Airway clearance technique

2

Other group

Description:

Autogenic drainage

Treatment:

Procedure: Airway clearance technique

3

Other group

Description:

R-C Cornet

Treatment:

Procedure: Airway clearance technique

4

Other group

Description:

Flutter

Treatment:

Procedure: Airway clearance technique

5

Other group

Description:

PEP

Treatment:

Procedure: Airway clearance technique