Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: the PREVENT study

Not Applicable

Completed

• Conditions: Respiratory; Chronic obstructive pulmonary disease (COPD); Other chronic obstructive pulmonary disease

• Registration Number: ISRCTN45572998
• Lead Sponsor: niversity Hospital Basel (Switzerland)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29266965

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-08
• Study Completion: 2014-04-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Aged greater than or equal to 40 years
2. Smoking history greater than or equal to 10 pack-years and moderate to very severe stable COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] II - IV without exacerbation for greater than or equal to 4 weeks)
3. History of severe exacerbation in previous year

Exclusion Criteria

1. Patients with pulmonary conditions other than COPD as the main respiratory disease
2. Rapid lethal disease
3. Severe immunosuppression
4. Known allergy or intolerance to the study medication
5. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber (%) of patients developing exacerbation within 21 days of URTI onset in the group receiving intensified combination therapy with inhaled steroids/LABA and placebo.

Secondary Outcome Measures

Name	Time	Method
Viral polymerase chain reaction (PCR) positivity during upper respiratory tract infection (URTI), exacerbations and stable periods; positive sputum bacteriology and positive PCR for atypical pathogens during exacerbation and stable periods; symptoms scores and MMRC dyspnea scale; therapy-related side-effects; duration and cumulative dose of steroids and antibiotics; hospital admission for any cause. Endpoints will be assessed 10 days after upper respiratory tract symptoms onset, after 21 days, in case of exacerbation, and in the stable period of the disease (at 6, 12, and 18 months). In a second step, endpoints will be assessed in subgroups of patients according to the COPD severity.