Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: a multinational, double-blinded, randomised controlled trial
Acronym
PREVENT
Study hypothesis
Background:
Most exacerbations of chronic obstructive pulmonary disease (COPD) are triggered by either bacterial or viral infection or a combination of both. A growing body of evidence implicates viral respiratory tract infection as the predominant risk factor associated with exacerbations of COPD. The synergism of corticosteroid and long-acting β2-agonists in suppressing viral-induced inflammation on airway epithelial cells has been demonstrated in vitro. However, high maintenance dose inhaled steroids is associated with serious adverse effects, particularly pneumonia, in patients with COPD. In asthma, a flexible regimen of inhaled corticosteroid and corticosteroid and long-acting β2-agonists (LABA) 'on-demand' in patients on low maintenance dose steroid/LABA significantly reduces steroid exposure while leading to a decrease in exacerbation rate as compared to a fix regimen of high maintenance dose steroid/ corticosteroid and long-acting β2-agonists. The efficacy of intensified combination therapy with inhaled corticosteroid/LABA at the onset of upper respiratory tract infection symptoms in COPD is unknown.
Aims:
1. To explore the role of different viral infections in exacerbations of COPD and its influence on bacterial co-infection, local and systemic inflammation, airway remodelling and systemic repercussions in patients with COPD
2. To evaluate whether intensified combination therapy with inhaled corticosteroids and long-acting β2-agonists at the onset of upper respiratory tract infection symptoms as compared to placebo decreases the incidence of exacerbation of COPD in patients receiving low maintenance dose inhaled corticosteroids/long-acting β2-agonists, thus reducing disease associated morbidity.
Ethics approval
Ethics Committee Basel - approval pending
Study design
Investigator-initiated and driven double blind randomised multinational trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic obstructive pulmonary disease (COPD)
Intervention
Additionally to the low maintenance dose steroid/LABA therapy (budesonide 200 µg/formoterol 6 µg bid), patients will be randomised to the combination corticosteroid/long-acting β2-agonists ('steroid/LABA group') or to placebo ('placebo group'). Patients in the steroid/LABA group will receive budenoside 400 µg/formoterol 12 µg bid in case of upper respiratory tract infection symptoms for 10 days. Patients randomised to the placebo group will receive inhaled placebo for 10 days. Low maintenance dose steroid/LABA therapy will be left unchanged in both groups.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number (%) 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
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.
Overall trial start date
01/01/2011
Overall trial end date
30/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
About 400 participants
Participant 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
Recruitment start date
01/01/2011
Recruitment end date
30/04/2014
Locations
Countries of recruitment
Belgium, Italy, Netherlands, Switzerland
Trial participating centre
University Hospital Basel
Basel
4031
Switzerland
Sponsor information
Organisation
University Hospital Basel (Switzerland)
Sponsor details
Clinic of Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29266965