Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: the PREVENT study
| ISRCTN | ISRCTN45572998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45572998 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/11/2010
- Registration date
- 08/12/2010
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Daiana Stolz
Scientific
Scientific
University Hospital Basel
Clinic of Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
Study information
| Study design | Investigator-initiated and driven double blind randomised multinational trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Preventing viral exacerbation of chronic obstructive pulmonary disease in upper respiratory tract infection: a multinational, double-blinded, randomised controlled trial |
| Study acronym | PREVENT |
| Study objectives | 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(s) | Ethics Committee Basel - approval pending |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2011 |
| Completion date | 30/04/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | About 400 participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 30/04/2014 |
Locations
Countries of recruitment
- Belgium
- Italy
- Netherlands
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Clinic of Pneumology and Respiratory Cell Research
Petersgraben 4
Basel
4031
Switzerland
| Website | http://www.unispital-basel.ch/ |
|---|---|
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2018 | Yes | No |
Editorial Notes
15/02/2018: Publication reference added.
