The Role of Respiratory Viruses in Exacerbations of Cystic Fibrosis in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01238081
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : June 1, 2012
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:

Respiratory viruses, such as those that cause colds and influenza, are very common in the general population. The average adult will experience between 2 and 4 viral respiratory illnesses each year. It is known that respiratory viruses can cause flare-ups of chronic lung diseases such as asthma and chronic obstructive pulmonary disease. In children with CF, respiratory viral infections have been identified in nearly half of all exacerbations and are associated with a decline in lung function and increased frequency of hospital admission and acquisition of new bacterial pathogens.

Currently, little is known about the impact of viral infections on the course of CF lung disease in adults and no large-scale prospective studies in this area have been performed to date. It is unknown how often respiratory viruses can be found in patients with CF when they are well and what consequences they have on the course of exacerbations of CF lung disease. This study will identify the frequency of common viral infections in adults with CF and determine the effects they have on lung function, the rate and diversity of bacterial infection and patients' treatment burden. The information gained from this study will lead to improved prevention and treatment of respiratory infections in CF.

Condition or disease
Cystic Fibrosis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 100 participants
Time Perspective: Prospective
Official Title: The Role of Respiratory Viruses in Exacerbations of Cystic Fibrosis in Adults.
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Identification of respiratory viruses in sputum, nose- or throat-swabs [ Time Frame: 12 months ]
    A panel of 6 viruses will be tested for using polymerase chain reaction (PCR)technology: adenovirus, rhinovirus, metapneumovirus, parainfluenza virus 1-3, influenza A,B&C and respiratory syncytial virus

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with cystic fibrosis attending the Manchester Adult Cystic Fibrosis Centre, Manchester, UK

Inclusion Criteria:

  • Patients with cystic fibrosis attending Manchester Adult CF Centre
  • Age ≥18 years
  • Capable of providing written informed consent
  • Able and willing to provide required samples and meet visit schedule

Exclusion Criteria:

  • Previous lung transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01238081

United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, Lancashire, United Kingdom, M23 9LT
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Principal Investigator: William G Flight, MBChB University Hospital of South Manchester NHS FoundationTrust

Additional Information:
Responsible Party: Manchester University NHS Foundation Trust Identifier: NCT01238081     History of Changes
Other Study ID Numbers: 2010CF004
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Manchester University NHS Foundation Trust:
Cystic fibrosis

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