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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01238081
First received: November 9, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Respiratory Viruses in Exacerbations of Cystic Fibrosis in Adults.

Resource links provided by NLM:


Further study details as provided by University Hospital of South Manchester NHS Foundation Trust:

Primary Outcome Measures:
  • Identification of respiratory viruses in sputum, nose- or throat-swabs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Serum


Enrollment: 100
Study Start Date: December 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with cystic fibrosis attending the Manchester Adult Cystic Fibrosis Centre, Manchester, UK

Criteria

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
  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: NCT01238081

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

Additional Information:
No publications provided

Responsible Party: University Hospital of South Manchester NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01238081     History of Changes
Other Study ID Numbers: 2010CF004
Study First Received: November 9, 2010
Last Updated: May 31, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by University Hospital of South Manchester NHS Foundation Trust:
Cystic fibrosis

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

ClinicalTrials.gov processed this record on July 24, 2014