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

This study has been completed.
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00890370
First received: April 28, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Procedure: Airway clearance technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Five Airway Clearance Techniques in the Treatment of Adults With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Forced expiratory volume in one second (FEV1) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (Short Form-36 and Chronic Respiratory Questionnaire) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Exercise capacity (Modified shuttle test) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: July 1999
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Active cycle of breathing techniques
Procedure: Airway clearance technique
2
Autogenic drainage
Procedure: Airway clearance technique
3
R-C Cornet
Procedure: Airway clearance technique
4
Flutter
Procedure: Airway clearance technique
5
PEP
Procedure: Airway clearance technique

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890370

Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Jennifer A Pryor, PhD Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Jennifer A Pryor, Royal Brompton & Harefield NHS Trust
ClinicalTrials.gov Identifier: NCT00890370     History of Changes
Other Study ID Numbers: 1998CF004B
Study First Received: April 28, 2009
Last Updated: April 28, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Cystic fibrosis
Airway clearance

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014