NCT01238081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

November 9, 2010

Last Update Submit

May 31, 2012

Conditions

Keywords

Cystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • Identification of respiratory viruses in sputum, nose- or throat-swabs

    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

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Previous lung transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of South Manchester NHS Foundation Trust

Manchester, Lancashire, M23 9LT, United Kingdom

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • William G Flight, MBChB

    University Hospital of South Manchester NHS FoundationTrust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 10, 2010

Study Start

December 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations