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

Cystic Fibrosis Clinical Trial

— ACT  

Official title:

A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890370
• Other study ID #: 1998CF004B
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2009
• Last updated: April 28, 2009
• Start date: July 1999
• Est. completion date: September 2003

Study information

• Verified date: April 2009
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• Airway clearance technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume in one second (FEV1)		48 weeks	No
Secondary	Quality of life (Short Form-36 and Chronic Respiratory Questionnaire)		48 weeks	No
Secondary	Exercise capacity (Modified shuttle test)		48 weeks	No