Condition category
Respiratory
Date applied
09/11/2010
Date assigned
08/12/2010
Last edited
08/12/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

University Hospital Basel
Clinic of Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland

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

The study protocol has been sent to the Ethic Committee Basel, Switzerland, on the 20th October 2010

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

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 measures

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

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

http://www.unispital-basel.ch/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes